Needle design for male transobturator sling

ABSTRACT

Described are surgical instruments for use in surgical procedures, related methods, systems, and kits, the instruments including features that optionally include one or more specific dimensions, and features that may result in an ergonomic advantage during use.

PRIORITY CLAIM

The present non-provisional patent application claims priority under 35USC §119(e) from U.S. Provisional Patent Applications having U.S. Ser.No. 60/650,208, filed on Feb. 4, 2005, by Arnal et al., and titledTRANSOBTURATOR SLING FOR MEN; U.S. Ser. No. 60/650,209, filed on Feb. 4,2005, by Arnal et al., titled TRANSOBTURATOR SLING FOR MEN; U.S. Ser.No. 60/659,714, filed on Mar. 8, 2005, by Arnal et al., titled NEEDLEDESIGN FOR MALE TRANSOBTURATOR SLING; U.S. Ser. No. 60/659,504, filed onMar. 8, 2005, by Arnal, titled NEEDLE DESIGN IMPROVEMENTS FOR MALETRANSOBTURATOR SLING; U.S. Ser. No. 60/677,457, filed on May 4, 2005, byHauschild et al., titled URETHRAL SLING OF KNITTED MESH WITH EDGETREATMENT; U.S. Ser. No. 60/683,185, filed on May 20, 2005, by Arnal,titled TRANSOBTURATOR SURGICAL SLING DELIVERY SYSTEM AND METHOD; andU.S. Ser. No. 60/650,207, filed on Feb. 4, 2005, by Rehder et al, titledTRANSOBTURATOR SLING FOR MEN, wherein the entirety of said provisionalpatent applications are incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to surgical tools, surgical implant, and relatedsystems and surgical methods.

BACKGROUND

Urinary incontinence is a significant health concern worldwide. In theurology field, needles, suture passers, and ligature carriers, are usedin a variety of procedures, many of which are designed to treatincontinence. Examples of such surgical instruments include Stameyneedles, Raz needles, and Pereyra needles. See Stamey, EndoscopicSuspension of the Vesical Neck for Urinary Incontinence in Females, Ann.Surgery, pp. 465-471, October 1980; and Pereyra, A Simplified SurgicalProcedure for the Correction of Stress Incontinence in Women, West. J.Surg., Obstetrics & Gynecology, pp. 243-246, July-August 1959.

A pubomedial sling procedure involves placement of a surgical implant inthe form of a urethral sling to stabilize or support the bladder neck orurethra, to treat incontinence. There are a variety of different slingprocedures. Descriptions of different sling procedures are disclosed inU.S. Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425; 5,899,909;6,039,686; 6,042,534; 6,110,101; 6,478,727; 6,638,211; PCT PublicationNos. WO 02/39890 and WO 02/069781.

Some pubomedial sling procedures extend a sling from the rectus fasciain the abdominal region to a position below the urethra and back againto the rectus fascia. Although serious complications associated withsling procedures are infrequent, they do occur. Complications includeurethral obstruction, prolonged urinary retention, bladder perforations,damage to surrounding tissue, and sling erosion.

The Tension-free Medial Tape (TVT) procedure (available from Ethicon, ofN.J.) uses a Prolene™ nonabsorbable, polypropylene mesh. Problems withthe TVT procedure are documented in the literature and patents. Problemsassociated with the TVT procedures and the like are acknowledged anddescribed in PCT publication nos. PCT WO 00/74613 and PCT WO 00/74594;U.S. Pat. Nos. 6,273,852; 6,406,423; 6,478,727; 6,638,210; 6,652,450;6,612,977; and 6,802,807. A cadaver study indicated that the TVT needleis placed in close proximity to sensitive tissue such as superficialepigastric vessels, inferior epigastric vessels, the external iliacvessel and the obturator. See, Walters, Mark D., PercutaneousSuburethral Slings: State of the Art, presented at the conference of theAmerican Urogynecologic Society, Chicago (October 2001) and PCTInternational Publication No. WO 02/26108.

Additional sling procedures are described in U.S. Pat. No. 6,478,727 andPCT Publication Nos. WO 02/39890 and WO 02/069781.

A significant percentage of pubomedial sling procedures are conductedafter previous pelvic surgery. A pubomedial sling procedure can beparticularly challenging if the patient has scarring as a result ofprevious pelvic surgery or other anatomical problems. The additionalcomplications presented by significant scarring present surgeons with agreater surgical challenge and may lead some surgeons to forego anotherwise beneficial sling procedure. Unfortunately, this reduces apatient's options for treating incontinence.

U.S. Pat. No. 6,638,211 describes an implantable device or tape for usein correcting urinary incontinence. The tape includes sprayedpolypropylene fibers that result in a strong implantable device. Thetape also has a silicone-coated portion and tapered free ends. Theprocedure uses an Emmet needle that includes an eyelet. To create theeyelet, the distal portion of the Emmet needle is enlarged. A surgicalprocedure using an Emmet needle is believed to be described in theFrench publication D. Dargent, S. Bretones, P. George, and G. Mellier,Pose d'un ruban sous uretral oblique par voie obturatrice dans letraitement de l'incontinence urinaire feminine, Gynecol. Obstet. Fertil.2002; 30: 576-582.

In the procedure described in U.S. Pat. No. 6,638,211, an incision ismade in the perineal skin facing the obturator and in the groin. TheEmmet needle is first inserted through the cutaneous incision. The Emmetneedle is first introduced perpendicular to the perineum for about 15 mm(passing through the internal obturator muscle as far as just outsidethe ischiopubic branch). The Emmet needle is then allowed to describeits curvature. The free end of the tape is then slipped into the eyeletof the needle. The needle and tape connection is thus reversible as onemerely needs to unthread the tape from the eyelet to separate the tapefrom the needle. Separation of the tape and needle while both are withinthe body is undesirable as it would require the needle to be repassedthrough the body. The needle with the tape extending through the eyeletis then pulled back though the skin incision. The eyelet and threadedtape present a sudden discontinuity encountered by the tissue that canmake tape and needle passage inconvenient and unnecessarily irritativeor traumatic to tissue. Additionally, the final placement of the slingmay not be optimum in this procedure.

There is ongoing research and development of new or improved medicalprocedures for treating incontinence. A recent development in treatingincontinence in men and women is the use of a transobturator tissue pathfor placement of a urethral sling. New and potentially useful andimproved surgical tools, slings, kits and systems are developed withinthis surgical subject matter.

SUMMARY

The invention relates to novel three-dimensional surgical tools andrelated methods for treating pelvic conditions including incontinence.

The tool comprises a handle portion and a needle portion with a distalregion that has structure in three dimensions. Unlike the Emmet needleof the prior art, the inventive instrument has substantial structure inthree dimensions. This three-dimensional needle portion is sized andshaped to extend between a “lateral” incision substantially adjacent thepatient's obturator foramen at the inner the thigh, and a “medial”incision that is located lateral from and substantially parallel to the“lateral” incision, e.g., an external incision in the perineal region ina male or an intravaginal incision in a female.

Exemplary needles can include a spacer extending from the handle, thespacer extending along a longitudinal axis shared with the handle andthe tool. At the end of the spacer begins a three-dimensional region ofthe needle that may be of any three-dimensional form useful forextending between incisions as described, curved or angular inthree-dimensions, and which may include portions that are in the form ofa helix, partial or variable helix, or a spiral.

The needle portion can also have structure near the needle distal end,at the distal end of the three-dimensional region, for associating theneedle with a component or portion of an implantable material fortreating the incontinence such as a urethral sling. The structure forassociating the instrument with an implantable material can comprise aneyelet or a dilator or other structure.

There are many vulnerable, sensitive pelvic anatomical structures andtissues in the region of the obturator foramen, including the pudendalartery (internal), the pudendal canal (Alcock), and nerves (e.g. theperineal and labial). The needles of the invention are preferably sizedand shaped to pass through the obturator foramen along a path that issubstantially free of vascular and nerve structures, either in men orwomen. The size and shape of the needles help avoid the sensitivestructures. The tip of the needle is preferably substantially blunt tohelp avoid damage to the sensitive structures. Alternatively, the tipmay be slightly sharpened to assist in the initial passage of theneedle.

The invention relates to different features of the tool, includingvarious dimensions of the handle, spacer, and three-dimensional region,and various spatial relationships between these features of the tool.

In certain tool embodiments, the handle portion, when viewed along thelongitudinal axis, is non-circular and includes a larger dimension orwidth. This width dimension defines a midplane of the handle when viewedalong the longitudinal axis.

Certain embodiments of the invention relate to the relative position ofthe needle distal end (which refers to the far end or tip of thethree-dimensional portion) relative to this midplane when the tool isviewed along the longitudinal axis. In general, the needle distal endcan be placed at an angle from the midplane to provide the user of thetool with an ergonomic advantage in allowing optimal force, sensitivity,and control of the tip when holding the handle using the midplane. Theparticular angle can depend on the type of procedure for which the toolis designed.

The tool can be used to install various surgical implants, such asimplants used to treat conditions of the pelvic region in men and women,an example being a urethral sling.

The invention also contemplates surgical kits or assemblies for treatinga pelvic condition such as incontinence. The assembly includes asurgical instrument as described, having a handle portion and a needlehaving substantial structure in three dimensions. The needle portion hasa portion that is sized and shaped to extend between an incisionsubstantially adjacent a patient's obturator foramen and a medialincision (in either direction). The assembly may also include animplantable article such as a urethral sling. Exemplary slings may beprepared from an implantable synthetic material and a sheath situatedabout the implantable synthetic material. A needle may optionallyinclude structure for associating the needle with the implant. Theassembly may further including a dilator for connecting the implant tothe needle. Alternately, a needle may comprise an eyelet for thatpurpose.

When the assembly includes a dilator, the dilator preferably hasengagement surfaces for connecting the dilator to the instrument. Thedilator is preferably operatively associated with the sheath andimplantable material. The structure of the needle portion in a distalregion comprises surfaces complementary with the engagement surfaces ofthe dilator for resisting separation of the instrument from the dilatoronce the two are engaged.

The needle portion can optionally be sized and shaped for apredetermined side of a patient, and the handle portion can includeindicia indicating the predetermined side of the patient, direction ofrotation during use in a surgical procedure, etc.

The invention also contemplates a surgical assembly comprising at leastone surgical tool, e.g., a first surgical instrument for use on a rightside of a patient. The first surgical instrument comprises a handleportion and a needle portion having substantial structure in threedimensions and a distal region. The needle portion has a portion that issized and shaped to extend between an incision substantially adjacentthe obturator foramen on the patient's right side and a medial incision(this needle may be referred to as a “left” hand tool because it may beheld by a surgeon during use with the surgeon's left hand). The assemblyalso has a second surgical instrument for use on a left side of apatient (sometimes referred to as the “right” hand tool). The secondsurgical instrument comprises a handle portion and a needle portionhaving substantial structure in three dimensions and a distal region.The needle portion of the second instrument has a portion that is sizedand shaped to extend between an incision substantially adjacent theobturator foramen on the patient's left side and a medial incision.

The assembly may also include an implant, such as a urethral slingcomprising implantable knitted polypropylene material and a sheathsituated about the implantable synthetic material. The first and secondsurgical instruments may include an eyelet for receiving a suture to tiethe surgical instrument to the implantable material. Alternatively, theassembly can have first and second dilators for associating the firstand second surgical instruments with the implantable material.

The invention also contemplates various methods for treatingincontinence using surgical implantation tools as described herein,including “transobturator” methods in men and women that include atissue path that traverses the obturator foramen.

An exemplary method comprises steps of creating a medial incision,creating an incision substantially adjacent the patient's obturatorforamen, providing an elongate surgical instrument comprising a needlehaving substantial structure in three dimensions, providing an implantfor treating the incontinence, passing the three dimensional region ofthe needle between the incisions, then associating the implant with theinstrument, and passing the implant through tissue and through thepatient's obturator foramen using the instrument. Preferably, the stepof providing an elongate surgical instrument includes the step ofproviding an instrument with a portion that is substantially helicallyshaped, and the step of passing the implant through tissue includes thestep of passing the implant along a substantially three-dimensional orhelical path. The step of providing a surgical instrument preferablyincludes the step of providing an instrument with an elongate handleportion having an axis, and the step of passing the instrument betweenthe incisions preferably includes the step of rolling the instrumentabout the axis of the handle portion.

In another aspect, the method comprises the steps of creating a medialincision, creating an incision substantially adjacent the patient'sobturator foramen, providing an elongate surgical instrument comprisinga handle portion, a needle portion having an extension portionprojecting from the handle portion and a variable spiral portion with adistal end, providing an implant for treating the incontinence, passingat least a portion of the variable spiral portion between the incisionsby initially passing the distal end through the incision substantiallyadjacent the patient's obturator foramen and then through the medialincision, then associating the implant with a portion of the instrumentthat has emerged from the medial incision, and then moving the distalregion of the instrument with the implant associated therewith from themedial incision toward the patient's obturator foramen to pass theimplant through tissue. Optionally, the step of associating the implantwith a portion of the instrument that has emerged from the medialincision includes the step of using a suture to tie the implant to aneyelet in the distal region of the needle.

In yet another aspect, the method comprises the steps of creating amedial incision, creating an incision substantially adjacent thepatient's obturator foramen, providing an elongate surgical instrumentcomprising first and second regions, providing an assembly having animplant for treating incontinence, initially passing the first region ofthe instrument initially through the medial incision toward the incisionsubstantially adjacent the patient's obturator foramen in a path throughthe patient's obturator foramen until the first region of the instrumentemerges from the incision substantially adjacent the patient's obturatorforamen, leaving the second region of the needle projecting from themedial incision, then associating the second region of the instrumentthat projects from the medial incision with the assembly, and thenmoving the instrument out of the patient's body to pass the implantthrough tissue from the medial incision toward the incisionsubstantially adjacent the patient's obturator foramen to place theimplant in a therapeutically effective position.

Another aspect of the invention relates to a surgical instrument forimplanting an implantable material to a pelvic region. The instrumentincludes: a handle having a longitudinal axis and an elongate widthdimension normal to the longitudinal axis, the elongate width dimensiondefining a midplane; and a needle portion extending from the handlealong the longitudinal axis. The needle includes a spacer portionconnected to the handle; a three-dimensional region connected to thespacer portion distal from the handle, and having structure in threedimensions; and a needle distal end at the distal end of thethree-dimensional region. The needle portion is sized and shaped toextend between an incision substantially adjacent to a patient'sobturator foramen, through the obturator foramen, and to a medialincision. The needle distal end is located at an angle between 20 to 70degrees from the midplane (when viewed along the longitudinal axis).

Another aspect of the invention relates to a surgical instrument forimplanting an implantable material to treat incontinence. The instrumentincludes: a handle and a needle extending from the handle. The needleincludes a spacer portion connected to the handle, a three-dimensionalregion connected to the spacer portion distal from the handle, and has astructure in three dimensions that includes a needle distal end at thedistal end of the curved portion. The needle portion is sized and shapedto extend between an incision substantially adjacent to a patient'sobturator foramen, through the obturator foramen, and to a perinealincision. The three-dimensional region has a length in the range from2.3 to 5 inches and a diameter in the range from 2.3 to 5 inches. Anaxis of the needle end portion lies within a plane that is orthogonal tothe longitudinal axis of the tool.

In another aspect the invention relates to a method of performing asurgical procedure. The method includes a step of rotating a surgicalinstrument having a handle comprising a midplane, about a longitudinalaxis. A surgical instrument is provided that includes a handle and afunctional section that engages with tissue, a surgical implant, or asurgical instrument. The handle includes an elongate dimension defininga midplane. The functional section is engaged with one or more oftissue, a surgical implant, and a surgical instrument. The handle isgrasped with the midplane approximately parallel to the palm. The handleis rotated using the hand such that during the rotation the handlerotates at least ninety degrees, and during ninety degrees of therotation the hand traverses ninety degrees between a forty-five degreeopen palm and a forty-five degree closed palm.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are views of a conventional surgical needle.

FIGS. 2A, 2B, and 2C, are views of a surgical needle that includefeatures of the invention as described.

FIGS. 3A and 3B are views of a surgical needle that include features ofthe invention as described.

FIGS. 4A and 4B are views of a surgical needle that include features ofthe invention as described.

FIGS. 5A and 5B are views of a surgical needle that include features ofthe invention as described.

FIGS. 6A and 6B are views of a surgical needle that include features ofthe invention as described.

FIGS. 7A and 7B are views of a surgical needle during exemplary use andmovement.

FIGS. 8A and 8B are views of a surgical needle during exemplary use andmovement.

FIGS. 9A, 9B, and 9C, illustrate a porous material and an exemplaryurethral sling prepared from the porous material.

FIG. 10 illustrates an exemplary step of a surgical procedure asdescribed.

FIG. 11 illustrates an exemplary step of a surgical procedure asdescribed.

FIG. 12 illustrates exemplary equipment useful for preparing an implant.

FIG. 13 illustrates exemplary equipment useful for preparing an implant.

FIG. 14 illustrates an exemplary processing step of preparing animplant.

All figures are schematic and not necessarily to scale.

DETAILED DESCRIPTION

The invention is directed to surgical tools and related methods usefulfor treating pelvic floor disorders such as incontinence or stressurinary incontinence (SUI) in both men and women. The invention is alsodirected to surgical kits and systems that involve the surgical toolsand methods.

The invention includes methods of treating urinary incontinence bysurgical implantation of a urethral sling, through a tissue path thattraverses the obturator foramen, in men and women. These“transobturator” methods generally involve two lateral incisions, eachat a right and left inner thigh of a patient, near a patient's obturatorforamen, and a third “medial” incision that can be at the perinealregion for men or at a vagina for women. The medial incision can be anexternal incision in the perineal region in a male, and can be anintravaginal incision in a female. An elongate urethral sling isinstalled to be located between the medial incision and the two lateralincisions with opposing end portions of the sling traversing eachobturator foramen. See, e.g., Assignee's copending United States PatentApplication Publication US2003/0171644 (U.S. Ser. No. 10/306,179) filedNov. 27, 2002, and entitled “Transobturator Surgical Articles andMethods,” and U.S. Ser. No. 11/347,047, entitled “Transobturator Methodsfor Installing Sling to Treat Incontinence, and Related Device,” filedon even date herewith, the entirety of each of these being incorporatedherein by reference.

Transobturator methods can involve dissection one or more tissue path,typically one on each of the patient's left and right sides between thelateral incision and the medial incision, by way of the obturatorforamen. Three-dimensional tools described herein can produce thesetissue paths in either direction. An “outside-in” approach dissects thetissue path by initiating the dissection at the lateral incision andproceeding through the obturator foramen in the direction of the medialincision. An outside-in approach generally will include a next step ofattaching an end portion of an implant to the needle distal end andretracting the needle back through the tissue path in a directionopposite the direction of dissection to pull the end portion of theimplant back through the tissue path.

An “inside-out” approach uses an opposite direction of dissection,initiating the dissection at the medial incision and proceeding throughthe obturator foramen in the direction toward the lateral incision. Aninside-out approach may require alternate steps to install the endportion of the implant, such as attaching an implant at the handle endof the tool (after removal of the handle), and pulling the end portionof the implant through the tissue path in the direction from the medialincision to the lateral incision. Other alternatives are also useful,such as attaching the implant end portion to the leading edge of thesurgical tool (at the needle distal end) before dissection, and pushingthe end portion through the tissue path at the same movement of thedissection. As yet another alternative the tissue path can first bedissected, the needle can be removed (retracted), an end portion of animplant can be associated with the needle distal end, and the needle andend of an implant can be re-passed through the tissue path from themedial incision to the lateral incision.

The invention involves tools useful in any of these transobturatorprocedures, or others. The tools include a handle portion (“handle”) anda needle portion extending from an end of the handle. The handle cannormally be elongate and define a longitudinal axis of the tool. Thehandle is optional and may be removably attached to the needle, or itmay be repositionably attached to the needle (such as for an“inside-out” approach that removes the handle and attaches an endportion of the implant at the trailing end of the tool to pull the endportion through a dissected tissue path). Alternatively, the handle maybe permanently attached to the needle. Suitable handles are described,for example, in U.S. Provisional Patent Application Nos. 60/347,494,60/336,884, and 60/343,658.

Exemplary needle portions extend from the handle starting with astraight “spacer” portion that extends from the handle along thelongitudinal axis of the tool, i.e., along a longitudinal axis sharedwith the handle. At the end of the spacer distal from the handle theneedle includes a three-dimensional region. The three-dimensional regionfeatures a shape and size in three dimensions that is designed to allowthe three-dimensional region to extend between a medial incision and alateral incision, in one direction or the other or in either direction.

An exemplary needle can have dimension and shape features sufficient toextend from a lateral incision adjacent the anterior side of the pubicbone, through the obturator foramen portion of the pubic bone, to aposition on the posterior side of the pubic bone, and to then emergefrom a medial incision made between the patient's obturator foramenincisions. Alternately, a needle may be shaped to extend along the sametissue path in the opposite direction, entering at the medial incisionand exiting at the lateral incision. A large number of different sizes,shapes, and dimensions of needles are suitable for the presentinvention.

Various portions of a tool, including handle, spacer, andthree-dimensional region, can include various inventive features orcombinations of inventive features related to shape, size, material, ordimensions of any of these components, or relative size or spatialrelationships between one portion of the tool and another portion of thetool. Any of the individual features may be useful according to thedescribed invention, and any of the features may also be useful incombination (including any possible combination of features) with in anyone or more of the other features described herein.

A three-dimensional region and a spacer can have any dimensions orcombination of dimensions to provide a tool useful for implanting apelvic implant, e.g., a urinary sling, using a transobturator method.The length of a spacer can provide a desired distance between a handleand the three-dimensional region of a tool. Exemplary length dimensionsof a spacer portion of the instrument, along a longitudinal axis of thedevice between a handle and a beginning of a three-dimensional region,can be from 0 to 3 inches, typically from 1 to 2.5 inches.

Another dimension of an inventive tool is the cross-sectional diameterof the needle, which can be the same or different along the length ofthe needle, but is generally a uniform dimension along the spacer andthree-dimensional region of a needle. The needle portion (spacer anddistal three-dimensional, e.g., helical, region) can be of a generallyrigid material such as a metal or rigid plastic, and can have agenerally circular cross section. For an exemplary needle made ofstainless steel (e.g., 17-4PHH900), a cross-sectional diameter of theneedle portion, including the spacer and the three-dimensional region,can be in the range up to 5 mm, e.g., a diameter in the range from 3 toabout 4 mm, such as a range that includes 0.125″.

A three-dimensional region of a needle can include a curved or angularformation that may be a full or partial helix, a variable helix, aspiral, or the like, in three-dimensions. The three-dimensional regionmay include regions that are straight, angular (e.g., cornered), orcurved optionally with increasing or decreasing radius. Thethree-dimensional region can be considered to include components thatinclude a proximal portion of the three-dimensional region generallystarting at the end of the spacer and extending to a needle end portion.The “needle end portion” includes: (1) a “needle distal end,” which isthe very end or tip at the far distal end of the needle; and, (2) a“needle end portion” is also considered to include an amount of theterminal length of the needle at the distal end such as the terminalinch of needle length adjacent to the needle distal end.

A needle end portion according to various embodiments of the toolsdescribed herein may be either straight or curved, or partially straightand partially curved. As an example, the terminal inch of the needle mayexhibit a curve that approximates or matches a curvature of the proximalregion of the three-dimensional region of the needle, extending to theneedle distal end. Alternately, the terminal inch may includeapproximately ½ inch of curved needle and a terminal ½ inch that isstraight. This terminal ½ inch may be an optional “engaging surface” or“securement surface” for engaging a portion of an implant, and may bestraight or curved.

For example, a three-dimensional region of a needle can include anengaging portion that exhibits no curvature, i.e., the engaging portioncan be straight for a desired distance at the end of the needle leadingto the needle distal needle end or “tip,” when the needle is viewedalong the longitudinal axis of the tool. A straight engaging portion maybe used for engaging a straight plastic dilator at an end of an implant.An exemplary straight engaging portion can be straight for a distancethat extends from the tip of the needle to a distance of 10 mm, e.g., upto 20 mm, from the needle distal end along the needle proximally towardthe handle, at which point the three-dimensional region of the needlebegins a curve in the form of a helix, spiral, or the like. Alternately,the engaging portion may be curved, e.g., along an arc that matches thethree-dimensional region of the needle. A curved engaging portion orneedle end portion may be desirable to allow the needle distal end todissect a curved path while the axis of the needle end portion isaligned with the tissue path being dissected; this may reduce traumaduring dissection.

Embodiments of the invention also relate to an “axis of the needle endportion,” which is a line projecting from the needle distal end. Theaxis of the needle end portion can be tangent to the needle at theneedle distal end for a curved needle end portion, and can be a linedefined by the needle end portion including the needle distal end for aneedle end portion that includes a terminal straight portion.

Also, in combination with other dimensions described herein, embodimentsof the invention can relate to a radial distance from the longitudinalaxis of the tool to the needle distal end. Exemplary radial distancesbetween a longitudinal axis and needle distal end may be from 0.5 to 2inches. For a tool designed for use with a male anatomy, an exemplarydistance may be from 0.7 to 1.7 inches, e.g., from 0.9 to 1.5 inch. Fora tool designed for use with a female anatomy, an exemplary distance maybe from 0.5 to 1.6 inches, e.g., from 0.7 to 1.3 inch.

A three-dimensional region can exhibit a length along the longitudinalaxis of the tool that is particularly suitable for a specific surgicalprocedure, such as a male transobturator installation of a urethralsling. This length of the three-dimensional region (e.g., spiral orhelix), can be the length measured along the longitudinal axis of thetool from the beginning of the three-dimensional region (e.g., startingat the end of a spacer) to the most distal extent of the needle,typically the needle distal end. Exemplary lengths of thethree-dimensional region can be in the range from about 1.5 inches andto about 3 inches, depending on the procedure and anatomy. Exemplarylengths of the three-dimensional region for a tool designed for use onthe female anatomy can be in the range from about 1.5 inches and toabout 2.5 inches, such as from 1.75 to 2.25 inches. Exemplary lengths ofthe three-dimensional region for a tool designed for use on the maleanatomy can be in the range from about 2.25 inches and to about 3inches, e.g., from 2.25 to 2.75 inches.

Another feature of a three-dimensional region of a needle, which can beuseful either alone or with other features described herein, is thediameter (or “width”) of the three-dimensional region. Thethree-dimensional region can have a diameter or “width” that ispreferably great enough to allow for passage of the three-dimensionalregion through a desired tissue path as described herein such as a patharound the inferior pubic ramus and through the natural opening of thepubic bone, while also being small enough to avoid sensitive structurein this region of the body. A diameter or “width” of a three-dimensionalregion can be measured as the distance from a line through an axis ofthe needle end portion, to a parallel line through a far opposing sideof the three dimensional portion of the needle, when viewed along thelongitudinal axis of the tool handle (see, e.g., FIG. 1A). Exemplarydiameters for the three-dimensional region for a tool can be in therange from about 1.25 inches and to about 5 inches, depending on theprocedure and anatomy. Exemplary width of a three-dimensional regionsuch as a helix as defined, for use in female transobturator methods maybe, e.g., in the range from 1.25 inches to less than 3 inches, such asfrom 2 inches to 2.25. To accommodate transobturator methods ofinstalling pelvic implants in a male anatomy, a diameter may begenerally larger than prior helical tools useful for implanting urethralslings. Exemplary diameters of a three-dimensional region such as ahelix as defined, designed specifically for use in male transobturatormethods may be, e.g., in the range from 2 inches to 5 inches, such asfrom 2 inches to 4 inches, e.g., from 2 to 3 inches.

Still another feature of a three-dimensional region of a needle that canbe useful alone or with other features described herein, can be that theneedle end portion of the three-dimensional region can lie within (ordefine) a line or a plane that is perpendicular to or orthogonal to thelongitudinal axis of the handle or the tool when the tool is viewed fromthe side. This means that the needle end portion, when the tool isviewed from a side perspective, can define a line that is substantiallyperpendicular to the longitudinal axis of the handle, the handle andspacer, or the tool. The line will not intersect the axis but whenviewed from a side of the tool will be at ninety degrees. Alternately,the needle end portion (e.g., if curved) can define a plane that issubstantially orthogonal to the longitudinal axis of the handle, thehandle and spacer, or the tool. This feature may be particularly usefulfor tools designed for the male anatomy, because a needle end portionthat is perpendicular to the longitudinal axis may assist in avoidingthe male prostate during use to dissect a transobturator tissue path.

Described differently, a three-dimensional region of a needle can followa path that lengthens as the needle defines a length and curvatureextending away from the handle or spacer to form a curvedthree-dimensional region. After defining a desired length-wise anddesired shaped of a three-dimensional needle extending a distance fromthe handle along the longitudinal axis of the handle, the needle maycontinue to extend in length but without extending a further distancefrom the handle along the longitudinal axis. This may define a line or aplane that can be viewed to be perpendicular or orthogonal to the axisof the handle. A desirable effect is that the three-dimensional regionof the needle can be sized and shaped to define a curved tissue pathbetween a medial and a lateral incision (in either direction) thatavoids contacting sensitive tissue, particularly with a male anatomy. Inspecific, by placing an axis of the needle end portion of thethree-dimensional region in a line or plane that is perpendicular ororthogonal to the axis of the handle, as described, the needle maydefine a tissue path that avoids the male prostate. For example, adesired length of the needle end portion that is within this plane maybe a terminal 1 inch, e.g., terminal 2 inches, for a tool designed to beused on the male anatomy. (The needle end portion may still be straightor curved).

In addition to features of the various portions of a tool, including thehandle, needle spacer, and needle three-dimensional region, theinvention also contemplates specific features of the handle portion andthe relation between the handle portion and one or more differentcomponents of the tool, such as the three-dimensional region of theneedle, which features can be used alone or in combination with any oneor more other features related to the particular shapes, sizes,material, or dimension of any the handle, spacer, or three-dimensionalregion of the needle.

In certain embodiments of tools of the invention, a handle or a portionof the length of a handle may exhibit a non-circular form when viewedalong the longitudinal axis of the handle. The non-circularcross-section can be, e.g., an oval, rectangle, rhombus, etc., havingone dimension (e.g., maximum dimension), a “width,” that is greater thanthe dimension perpendicular to that “width.” The non-circular form willprovide one or more surfaces on the handle for a surgeon to placepressure onto and to achieve a grip. The non-circular cross-sectionalform also defines a midplane that is a plane that includes thelongitudinal axis of the handle and extends along the width or thewidest dimension of the handle when viewed in cross section along thelongitudinal axis.

Tools described herein may include a needle distal end that is locatedat any useful position relative to a midplane and a longitudinal axis ofa handle of the tool. An angle between the needle distal end and amidplane can be defined as the angle between the needle distal end andthe midplane when the tool is viewed along the longitudinal axis,viewing in the direction looking at the three-dimensional region of thetool, with the longitudinal axis of the tool taken as an origin forpurposes of defining the angle. This view is illustrated in FIGS. 7A,7B, 8A, and 8B, among others.

According to embodiments of the invention, a needle distal end of a tool(measured at the tip of the needle distal end) may be located at aposition in space relative to the handle midplane and longitudinal axis,to provide the user with an ergonomic advantage. The ergonomic advantagemay relate to useful or optimized (e.g., increased) amounts of force andcontrol that can be applied at the needle distal end during aninstallation procedure, meaning amounts of force, sensitivity, andcontrol that the user will have over the needle distal end whenmanipulating the handle using the midplane for leverage or grasping. Asan example, a needle distal end may be located at an angle relative tothe midplane to provide an ergonomic strength advantage or controladvantage to a surgeon during particularly risky or sensitive portionsof a surgical procedure, such as portions of a surgical procedure thatinvolve using the needle distal end to dissect a tissue path through ornear sensitive organs or tissues, e.g., traversing the obturatorforamen. The angle between the needle distal end and the midplane mayprovide the surgeon with the use of maximum hand or wrist strength andmaximum control and precision during manipulation of the needle distalend through a sensitive or risky tissue path, when applying pressure toa handle having a midplane.

In more detail, when the human hand holds an instrument having a handle,using the palm, fingers, and thumb (as in FIGS. 7A, 7B, 8A, and 8B), androtates the handle about an axis that approximately lines up with anaxis of the wrist and forearm, the human hand and wrist exhibitdifferent amounts of strength and control (precision of control)depending on the rotational orientation of the hand and wrist relativeto the forearm. When the forearm is held horizontally and the hand holdsa handle of a surgical tool having a midplane, with the longitudinalaxis situated horizontally along the palm, the wrist (i.e., hand, wrist,and forearm) can exert the greatest amount of force and control to thehandle when the palm of the hand is oriented vertically and within arange of positions from 45 degrees past vertical in either direction(i.e., “opened” or “closed” up to 45 degrees from a vertical palm). Asused herein, an “open” hand or wrist posture refers to a posture of auser's hand held with an approximately horizontal forearm with the palmoff of vertical (e.g., 45 degrees from vertical) in a direction thatplaces the palm in a direction facing upward from horizontal (e.g., 45degrees up or open from vertical) (see FIGS. 7B and 8B); a “closed” handor wrist posture refers to a posture of a user's hand held with ahorizontal forearm, with the palm off of vertical (e.g., 45 degrees fromvertical) in a direction that places the palm in a direction facingdownward from horizontal and the user may partially view the back of thehand; (see FIGS. 7A and 8A).

The vertical palm posture is most natural for the hand, and 45 degreespast vertical in either an opened or a closed direction will besufficiently near the natural vertical position to provide a range ofmaximum or optimal control and strength for manipulating a handle havinga midplane. According to embodiments of the invention, a handle midplaneand needle distal end can be positioned relative to each other so thatwhen rotating the tool to for use in a surgical procedure (e.g., toinstall a surgical implant), movement of the user's hand will includerotational movement of the hand within the ninety degree range of motion(within the range up to 45 degrees on either side of a vertical palm)that provides maximum control and strength, particularly duringsensitive, risky, or control-critical steps of an installationprocedure. The relative positions of a midplane and needle distal end,including angles and distances, can be selected for any particularsurgical procedure, and may be different for different surgicalprocedures, e.g., for particular tissue paths or different directions ofa tissue path being dissected.

A relatively sensitive portion of a transobturator procedure, in a maleor female, can involve dissecting a tissue path connecting a lateralincision and a medial incision while traversing the obturator foramen.The lateral incision is near the patient's obturator foramen. The medialincision may be near the perineum in a male, such as between the corpusspongiosum and the corpus cavemosum, or at or near a vaginal incision inwomen. The tissue path can be dissected in either direction, using an“inside-out” or an “outside-in” technique. For an “outside-in” approachthe tissue path can be initiated by positioning the needle distal end ata lateral incision; the tool is rotated to cause the needle distal endto enter the lateral incision and then to traverse the obturatorforamen; and the tool is rotated further to cause the needle distal endto exit the tissue path at a location at or near a medial incision. Foran “inside-out” dissection, the tissue path is initiated by insertion ofthe needle distal end at the medial incision, the tool is rotated tocause the needle distal end to traverse the obturator foramen, and thetool is further rotated to cause the needle distal end to exit at thelateral incision.

The step of dissecting a tissue path between a lateral and a medialincision, in either direction, requires training and high sensitivityand control of the needle distal end of the surgical tool, using thehandle, to avoid damaging sensitive structures such as nerves or otherorgans within and near the obturator foramen, and also to guide theneedle distal end to a desired exit position. The tissue path can betraversed using a needle as described herein, with rotation of thehandle over a range of at least ninety degrees, generally somewhatgreater than ninety degrees. According to embodiments of the invention,the tool can be designed so that rotation of the tool handle to causethe needle distal end to define and traverse this tissue path occurs byrotating the user's wrist through a range that includes the ninetydegree range of motion through which the wrist exhibits maximum controland strength.

In specific embodiments, a handle having a midplane can allow improvedleverage (e.g., torque) and control when applying force from the handleto the needle distal end. A handle midplane can be oriented relative toa needle distal end so the user has maximum control and strength throughapproximately 90 degrees of motion traversed in using the needle distalend to dissect a tissue path between a lateral incision, through anobturator foramen, and to a location at or near a medial incision (orthrough the same tissue path in the opposite direction). The particularangle may differ depending on factors such as the type of procedure thatthe tool is used for, the tissue path, and the direction of movement ofthe three-dimensional region of the needle when defining a tissue path.

For a three-dimensional tool designed for a male or femaletransobturator procedure, the relative orientations of the handlemidplane and the needle distal end can position the needle distal end atthe starting point of a tissue path that traverses the obturatorforamen, while the user's hand is positioned at or near the beginning ofthe ninety-degree range of maximum wrist strength and control and theuser's palm is at least forty-five degrees opened or closed fromvertical (e.g., 50 or 55 degrees opened or closed from vertical, or evenup to 80 or 90 degrees from vertical). For an outside-in procedure, theneedle distal end may be positioned at a starting point that places theneedle distal end at an entry of a lateral incision; for an inside-outprocedure, the needle distal end may be positioned at a starting pointthat places the needle distal end at an entry of a medial incision.

Another feature that can be incorporated into a tool as described hereinto improve ergonomics and provide improved strength and control of aneedle distal end by manipulation of a handle having a midplane, is therelation between a handle midplane and an axis of the needle endportion. This angle can be defined when viewing the tool along thelongitudinal axis, looking at the end of the tool that includes thethree-dimensional portion, e.g., as in FIGS. 7A, 7B, 8A, and 8B. An axisof a needle distal end can be a line or tangent defined by the needle atthe needle distal end when the tool is viewed along the longitudinalaxis.

According to embodiments of the invention, an axis of the needle endportion can be oriented relative to a handle midplane so that the needledistal end can be rotated to define a tissue path that traverses theobturator foramen with favorable ergonomic control and strength, andwith ease of passage of the needle distal end and reduced trauma totissue. For example, the axis of the needle end portion may preferablybe approximately tangential to a circle about the longitudinal axis ofthe tool at the radius of the needle distal end. For a curved needle endportion, a line tangent to the needle distal end can be tangent to acircle having an origin at the longitudinal axis, or at an angle that isup to 5, 10, or 15 degrees from tangent. Placing the needle end portionor needle distal end at or near a tangent of a circle having a radiusdefined by the needle distal end, can place the axis of the needle endportion or needle distal end in line with the direction of advancementof the needle distal end, during rotation, to allow the needle distalend to be pointing in the direction of advancement of the needle distalend when creating a tissue path; stated differently, the needle distalend can be relatively perpendicular to tissue as the needle distal endis rotated to dissect tissue and define a curved tissue path.

Another optional feature useful in combination with the described anglesbetween a needle distal end, axis of needle distal end, and a handlemidplane, can be a radial distance from the longitudinal axis of thetool to the needle distal end (tip), which provides desired utility oran ergonomic advantage.

FIG. 7A shows left-handed tool 150 (for use on a patient's right side)held by a user's left hand, and for use to form a tissue path using anoutside-in tissue dissection technique. Handle midplane 152 is orientedapproximately 45 degrees from horizon 154. Axis 156 of needle distal end158 is about ninety degrees from horizon 154, meaning that axis 156 isapproximately vertical as the needle distal end will enter a lateralincision, and makes an angle of approximately 45 degrees with midplane152 (angle Y). Distance d represents the radial distance from alongitudinal axis of tool 150 to distal end 158. From the illustratedorientation the user will rotate the left hand and the toolcounterclockwise (from the user's perspective, clockwise as illustrated)to dissect and define a tissue path traversing the obturator foramen.The needle distal end traverses forty-five degrees as the hand rotatescounter-clockwise and partially opens to a vertical hand orientation.The needle distal end traverses another forty-five degrees past verticalas the hand opens further, for a total of ninety degrees through a rangeof motion that includes hand and wrist motion of maximum strength andcontrol. During this movement the needle distal end (158) traverses theobturator foramen. At the end of the movement or shortly thereafter,needle distal end 158 will be located at a position near a medialincision at the vagina in a female or at a perineal location in a male.FIG. 7B shows the hand and tool orientation after the tool has beenrotated ninety degrees.

FIGS. 7A and 7B show an operator using a left hand to operate aleft-handed tool, e.g., to install a portion of an implant at apatient's right side. The ergonomic advantages of the design ofleft-handed tool 150 would also apply if the user were to instead usehis or her right hand to operate the left-handed tool of FIGS. 7A and7B, for installing a portion of an implant in a patient's right side. Inthat embodiment, the right hand would start by holding the handle oftool 150 with the tool in the same orientation is shown in FIG. 7A. Thetool handle midplane would be at the same 45-degree orientation fromhorizon 154 but the user would hold the tool with the right hand insteadof the left hand. In a surgical setting the right hand may be crossed infront of the surgeon's body. The right hand, however, would hold thehandle with a right hand posture that is approximately 45 degrees fromvertical in an open posture. The right hand would rotate 45 degrees toapproximately a palm-vertical posture, and would finish the rotationthrough 45 degrees to place the right hand and wrist at a 45 degreeclosed posture, or beyond.

FIGS. 8A and 8B illustrate a right-handed tool for use in installing aportion of an implant on a patient's left side using an outside-intissue dissection approach. Tool 160 is held by a user's right hand withhandle midplane 162 oriented approximately 45 degrees from horizon 164.Axis 166 of needle distal end 168 is about ninety degrees from horizon164, meaning that axis 166 is approximately vertical as the needledistal end will enter a lateral incision, and makes an angle ofapproximately 45 degrees with midplane 162 (angle Y). From theillustrated orientation, the user will rotate the right hand and thetool clockwise from the user's perspective, counter-clockwise asillustrated, to dissect and define a tissue path traversing theobturator. The needle distal end traverses forty-five degrees as theright hand rotates clockwise and partially opens to a vertical handorientation. The needle distal end traverses another forty-five degreespast vertical as the hand opens further, for a total of ninety degreesthrough a range of motion that includes hand and wrist motion of maximumstrength and control. During this movement needle distal end 168traverses the obturator foramen. At the end of the movement or shortlythereafter the needle distal end will be located at a position near amedial incision at the vagina in a female or at a perineal location in amale. FIG. 8B shows the hand and tool orientation after the tool hasbeen rotated ninety degrees.

Specific angles and dimensions between a needle distal end and amidplane can depend on features of a tool design such as the intendedsurgical procedure that the tool will be used for and the type ofanatomy (male or female). For a tool use to dissect a tissue path usingan “outside-in” technique (see, e.g., FIGS. 7A and 7B) thethree-dimensional portion may generally consist of a curved needleoriginating from a longitudinal axis of the tool, e.g., at a spacer.When viewed along the axis from the end at the three-dimensional regionas in FIG. 7A, and with midplane 152 representing a Cartesian x-axis,the needle starts from the origin (O) moving initially in a directionhaving a tangent approximately in a downward direction along thenegative y axis. The needle lengthens with a clock-wise rotation (fromthis view) to define an increasing-radius spiral or helix that makes apass through at least 180 degrees around the x and y axes, and up to oroptionally exceeding 270 degrees, e.g., from 200 to 250 degrees, such asfrom 220 to 245 degrees or from 230 to 240 degrees. According toembodiments of the invention, when viewed as described, a needle distalend of such a left-handed tool for an outside-in procedure may terminateat a location that is in the first quadrant of Cartesian coordinates. Asillustrated at FIG. 7A, angle “X” between needle distal end 158 andmidplane 152 (with origin at the tool longitudinal axis) can be from 20to 70 degrees, preferably from 25 to 50 degrees, e.g., from 30 to 40degrees. This angle X as shown in FIG. 7A is a positive angle with theneedle distal end being located within the first quadrant of Cartesiancoordinates. Optionally and preferably, the radial distance (d) from thelongitudinal axis (origin, “O”) to needle distal end 158 can be in therange from 0.5 to 2 inches, e.g., from 0.7 to 1.7 inch for a male tool,e.g., from 0.5 to 1.6 inches for an exemplary female too. Alsooptionally, for an outside-in transobturator procedure, angle Y betweenmidplane 152 and axis 156 of needle distal end 158 can be in the rangefrom about positive 30 to 60 degrees, such as from positive 40 to 50degrees, or from positive 42 to 48 degrees, in the first or thirdquadrant of Cartesian coordinates. For a tool designed for an“inside-out” procedure, the magnitude of the angles would be similar(i.e., 30 to 60 degrees, etc.,) but a needle end portion would belocated below the x-axis of a Cartesian system in the third or fourthquadrant, e.g., depending on whether the tool is a left-hand or aright-hand tool; the angles may be considered to be “negative” angles ofthe same magnitude. See FIG. 2C.

For a right-handed tool as in FIGS. 8A and 8B the dimensions and angleswould be similar except in a mirror-image of the left-handed tool ofFIGS. 7A and 7B. Distance d and angles X and Y have the same values butlie in different quadrants of a Cartesian coordinate system. Withmidplane 162 taken as the x-axis of a Cartesian system, as illustrated,needle distal end 168 is located in the second quadrant, with angle Ystill being positive.

FIGS. 1A-1B illustrate two views of a prior art tool used to install aurethral sling by a transobturator method, e.g., with female anatomy.FIG. 1A illustrates a view of tool 10 along a longitudinal axis of thetool. FIG. 1B illustrates a side view of tool 10. Tool 10 includeshandle 12 and a needle extending longitudinally from an end of thehandle along the longitudinal axis of the handle. The needle includesspacer 14 and three-dimensional region 16 which may be considered to bea helix or a spiral. The diameter 18 of three-dimensional region 16 ismeasured from the axis 25 of needle distal end 20, to a parallel linethrough the far side of the three-dimensional region. The length ofspacer 14 is indicated as length 24 between the end of handle 12 and thebeginning of three-dimensional region 16. The length ofthree-dimensional region 16 is indicated as length 26. The illustratedembodiment of a tool includes straight needle end portion 24, whichincludes a straight end portion having a length of approximately theterminal 0.75 inch of the needle. Needle end 24 as illustrated isstraight, including a straight engaging portion 23, which is about 0.5inches.

FIGS. 2A and 2B illustrate two views of a tool that includes featuresaccording to the invention. FIG. 2A illustrates a view of tool 30 alonga longitudinal axis of the tool. FIG. 2B illustrates a side view of tool30. Tool 30 includes handle 32 and a needle extending longitudinallyfrom an end of handle 32 along longitudinal axis 33 of the handle andtool. The needle includes spacer 34 and three-dimensional region 36which may be considered to be a helix, a variable helix, or a spiral,etc. Diameter 38 can be as desired for either a male or femaleprocedure. For a male transobturator design, diameter 38 can be largerthan diameters of relevant prior art tools, and may be, for example, inthe range from 2 to 5 centimeters, e.g., about 2.4 inches. Length 42 ofspacer 34 can be any desired length; for installing a urethral sling inmale anatomy by a transobturator tissue path, a preferred length 42 canbe, for example, in the range from 1 to 5 inches, e.g., from 1.75 to2.25 inches. Length 40 of three-dimensional region 36 can be any desiredlength, and for a male transobturator procedure may preferably be in therange from 2.25 to 5 centimeters, e.g., from 2.4 to 2.5 inches. Angle Yis approximately 45 degrees, and angle X is approximately 30 degrees.Using these angles to provide an ergonomic advantage for an outside-intransobturator installation procedure, the dimensions such as width andlength of the three-dimensional region may be smaller or larger, whilestill achieving an ergonomic advantage for a male or a female anatomy.Smaller dimensions can be useful if the tool is being designed for aprocedure on the female anatomy.

Other inventive features are also illustrated in FIGS. 2A and 2B. Forinstance, needle end portion 44, which includes a length of about oneinch at the end of the needle, is curved up until engaging portion 49,which is straight. This differs from needles that include a straightportion leading up to and adjacent to an engaging portion, such as theprior art needle shown in FIGS. 1A and 1B.

Also illustrated in FIGS. 2A and 2B is an inventive feature related tothe positioning of needle distal end 50 relative to midplane 48 ofhandle 32. Needle distal end 50 is located relative to midplane 48 toallow an ergonomic advantage by a surgeon during an outside-intransobturator installation procedure, which involves improve torque orstrength applied to handle 32 when inserting an implant using theneedle. When tool 30 is viewed along the longitudinal axis from thedistal end of tool 30, looking in a direction from the distal end towardthe proximal end, needle distal end 50 is located at an angle of about30 degrees from midplane 48 (angle X).

Also illustrated in FIG. 2B is the feature of an axis of needle endportion line 52 or plane defined by the distal end portion that issubstantially orthogonal to the longitudinal axis of handle 32. Distalend portion 44 can define either a line or a plane, depending on, e.g.,whether the distal end portion is straight or curved. In FIG. 2A, distalend portion 44 includes a curve, and as such defines a plane includingneedle distal end 50. This plane, illustrated as line 52, issubstantially orthogonal to the longitudinal axis of tool 30.

Radial distance 51 of tool 30 can be as desired and as described herein,and may differ for a female transobturator tool compared to a maletransobturator tool. An exemplary radial distance for a female tool maybe from 0.5 to 1.6 inches, and for a male tool may be from 0.7 to 1.7inches.

FIGS. 2A and 2B illustrate a tool designed for an inside-out approach. Atool with similar features, designed for an inside-out method ofcreating a tissue path, is shown at FIG. 2C (having number designationssimilar to those of FIG. 2A). FIG. 2C illustrates a tool for use in atransobturator procedure on a patient's left side (using a surgeon'sright or left hand); the needle distal end lies in the fourth quadrant.A tool for use in a transobturator procedure on a patient's right sidewould include a needle distal end that lies in the third quadrant.Either tool can preferably include an angle X that is a “negative” anglerelative to midplane 48 (that places needle distal end 50 below midplane48 when viewed as illustrated, in the range from 20 to 70 degrees, e.g.,from 25 to 50 degrees, or from 30 to 40 degrees.

FIGS. 2A and 2B illustrate a handle midplane angled differently relativeto the needle distal end, compared to the orientation shown in FIG. 1A.FIGS. 3A and 3B illustrate a needle according to another embodiment ofthe invention wherein the needle distal end is about parallel with thehandle midplane. Additionally, the straight portion at the needle endportion of tools 30 and 60 extends along the engaging portions 49 and73, respectively, of the needles, and not proximally beyond thoseengaging portions, as compared to the tool of FIG. 1A, which includes astraight portion 24 of the needle proximal to an engaging portion 23.The overall diameter of the three-dimensional regions of the needles ofthe tools illustrated at FIGS. 2A, 2B, 3A, or 3B, can be selected basedon specific procedures and anatomy, and may be prepared for use withmale or female anatomy.

FIGS. 3A and 3B illustrate a surgical needle that includes otherfeatures of inventive tools described herein. FIG. 3A illustrates a viewof tool 60 along a longitudinal axis 62. FIG. 3A illustrates a side viewof tool 60. Tool 60 includes handle 64 and a needle extendinglongitudinally from an end of the handle along longitudinal axis 62 ofthe handle. The needle includes spacer 66 and three-dimensional region68 which may be considered to be a helix, variable helix, a spiral, etc.Tool 60 includes needle end portion 70, which includes a length ofapproximately 1 inch at the end of the needle, including engagingportion 71 adjacent to needle distal end 72. According to the embodimentof FIGS. 3A and 3B, the overall diameter of three-dimensional region canbe larger when compared to relevant prior art needles, especially for atool 70 designed for use with a male transobturator procedure. Also, asillustrated, needle end portion 70 defines a plane or a line (63) thatfalls within a plane that is orthogonal to longitudinal axis 62. Tool 60includes needle end portion 70, which includes a curved portion (71) anda straight engaging portion (73), ending at needle distal end 72. Needleend portion 70, including engaging portion 73, is approximately parallelto midplane 74 of handle 64. Three-dimensional region 68, except forengaging portion 73, does not include any other portion that isstraight.

FIGS. 4A and 4B are various views of yet another surgical needle, 80,having handle 82, three-dimensional region 84, midplane 86, longitudinalaxis 88, needle distal end 90, and line or plane 92 defined by needleend portion 99. Needle end portion 99 is illustrated to include a curvedportion 97 and a straight engaging portion 95. Tip 90 is at an angle ofabout 25 degrees from midplane 86 to allow improved torque during use.Optionally, in particular for use in male transobturator procedures, thediameter, length, or both of three-dimensional region 84 can be largerthan conventional needles, such as a width 98 of about 2.3 to 2.6 inchesand a length of about 2.3 to 2.6 inches. As illustrated, a plane thatincludes axis 92 of needle end portion 94 is orthogonal to longitudinalaxis 88.

According to another embodiment of the invention, FIGS. 5A and 5B arevarious views of another inventive surgical needle wherein the handle ispositioned relative to the needle distal end to provide an ergonomicadvantage for the user, and wherein there is a flat (i.e., straight)section near the needle distal end. FIGS. 5A and 5B illustrate surgicalneedle 102 having handle 110, three-dimensional region 112, midplane114, longitudinal axis 116, needle distal end 120, width 119, and line118 defined by needle end portion 104. Needle end portion 104 includesstraight or flat needle portion 106 and straight engaging portion 108.Needle distal end 120 is located radially from axis 116 at an angle ofabout 25 degrees from the midplane 114 to allow improved torque duringuse. Optionally, the diameter, length, or both of three-dimensionalregion 112 can be larger than conventional needles, such as a diameterof about 2.4 inches and a length of about 2.4 to 2.5 inches. Asillustrated, line 118, defined by straight needle end portion 104, lieswithin a plane perpendicular to longitudinal axis 88 when viewed from aside of tool 110, e.g., as in the side view of FIG. 5B. Line 118 is notin the same plane as axis 116 and does not intersect axis 116.

FIGS. 6A and 6B illustrate yet another surgical needle. Features of thisembodiment include an axis 140 of a needle distal end that is bent awayfrom the handle (as in FIG. 1A), optionally a diameter of thethree-dimensional region that is for either a male or a female anatomy.FIGS. 6A and 6B illustrate views of a surgical needle wherein the handleis positioned relative to the needle distal end to provide an ergonomicadvantage for the user, and wherein there is a flat (i.e., straight)section 130 of the three-dimensional portion of the needle, near needledistal end (when viewed along the axis), in accordance with anotheraspect of the invention. FIGS. 6A and 6B illustrate surgical needle 122having handle 124, three-dimensional region 134, midplane 126,longitudinal axis 138, needle distal end 136, and line 140 defined byneedle end portion 128. Needle end portion 128 includes straight or flatportion 130 and straight engaging portion 132, each of which is straight(not curved) when viewed along longitudinal axis 138. Needle distal end136 is at an angle of about 25 degrees from midplane 126, to allowimproved torque during use. Optionally, the diameter, length, or both ofthree-dimensional region 134 can be for male or female procedures; formale procedures length 133 and diameter or width 131 can be larger thanconventional needles, such as a diameter of about 2.4 inches and alength of about 2.3 to 2.6 inches. As illustrated, line 140, defined byaxis of straight needle end portion 113, is slightly angled to and notperpendicular or orthogonal to longitudinal axis 138, e.g., when viewfrom a side of tool 122, e.g., as in the side view of FIG. 6B. Line 140is not in the same plane as axis 138 and does not intersect axis 138.

The needle of a tool can be made of a durable, biocompatible surgicalinstrument material such as, but not limited to, stainless steel (e.g.,316 stainless steel or 17-4 stainless steel), titanium, Nitinol,polymers, plastics and other materials, including combinations ofmaterials. The needle should have sufficient structural integrity towithstand the various forces (e.g. forces caused by dilator attachment,and penetration/passage of the needle through the various tissues)without undergoing any significant structural deformation. Optionally,the needles could be sufficiently malleable to allow a practitioner oruser of the device to modify the needle to a desired shape and, thereby,optimize the procedural approach.

Needles may be disposable or reusable (e.g. sterilizable by steamsterilization procedures). In another aspect of the present invention,the needles may be provided in a kit, such as any of the kits describedin any of U.S. Pat. Nos. 6,612,977; 6,641,525; 6,652,450; 6,802,807;published U.S. Pat. Application No. 2002-0147382-A1; and U.S.Provisional Application Ser. Nos. 60/263,472, filed Jan. 23, 2001;60/269,829, filed Feb. 20, 2001; 60/281,350, filed Apr. 4, 2001;60/295,068, filed Jun. 1, 2001; and 60/306,915, filed Jul. 20, 2001.

One embodiment of kit includes the needle and other needles (not shown,but for example including the needles shown in published U.S. Pat.Application No. US-2002-0099258-A1) designed for placing a sling, underthe urethra.

In another aspect of the present invention, a needle may optionallyinclude the capacity to deliver a medicament (e.g. anesthesia) duringthe surgical procedure. For example, the needle may be hollow with anopen end. The needle may have a connector for associating with amedicament reservoir and delivery mechanism (e.g. a syringe).

Needles as described may be used in conjunction with a wide variety ofsling materials and sling assemblies. The sling may be integral,monolithic, or a composite of different components or segments ofdifferent components. Suitable non-synthetic materials includeallografts, homografts, heterografts, autologous tissues, cadavericfascia, autodermal grafts, dermal collagen grafts, autofascialheterografts, whole skin grafts, porcine dermal collagen, lyophilizedaortic homografts, preserved dural homografts, bovine pericardium andfascia lata. Suitable synthetic materials for a sling includepolymerics, metals and plastics and any combination of such materials.

Commercial examples of non-absorbable materials include Marlex™(polypropylene) available from Bard of Covington, RI, Prolene™(polypropylene) and Mersilene (polyethylene terephthalate) Hernia Meshavailable from Ethicon, of New Jersey, Gore-Tex™ (expandedpolytetrafluoroethylene) available from W. L. Gore and associates,Phoenix, Ariz., and the polypropylene sling available in the SPARC™sling system, available from American Medical Systems, Inc. ofMinnetonka, Minn. Commercial examples of absorbable materials includeDexon™ (polyglycolic acid) available from Davis and Geck of Danbury,Conn., and Vicryl™ available from Ethicon. Other examples of suitablematerials include those disclosed in published U.S. Pat. Application No.2002/0072694. More specific examples of synthetic sling materialsinclude, but are not limited to polypropylene, cellulose, polyvinyl,silicone, polytetrafluoroethylene, polygalactin, Silastic, carbon-fiber,polyethylene, nylon, polyester (e.g. Dacron) PLLA and PGA. The slingmaterial may be resorbable, absorbable or non-absorbable. Optionally,some portions may be absorbable and other portions may benon-absorbable.

The synthetic slings may be knitted, woven, sprayed or punched from ablank. Some slings may be sufficiently robust to be inserted without aprotective sleeve. In other embodiments, some synthetic slings may havean associated protective sleeve to assist with the implantation.

According to certain embodiments, a sling may comprise a mesh material.The mesh material comprises one or more woven, knitted or inter-linkedfilaments or fibers that form multiple fiber junctions throughout themesh. The fiber junctions may be formed via weaving, knitting, braiding,bonding, ultrasonic welding or other junction forming techniques,including combinations thereof. In addition, the size of the resultantopenings or pores of the mesh may be sufficient to allow tissuein-growth and fixation within surrounding tissue. As an example, notintended to be limiting, the holes may comprise polygonal shaped holeswith diagonals of 0.132 inches and 0.076 inches.

The quantity and type of fiber junctions, fiber weave, pattern, andmaterial type influence various sling properties or characteristics. Asanother example, not intended to be limiting, the mesh may be wovenpolypropylene monofilament, knitted with a warp tricot. The stitch countmay be 27.5 courses/inch (+ or −2 courses) and 13 wales/inch (+ or −2wales). The thickness of this example is 0.024 inches. This embodimentof sling is preferably associated with a protective sleeve (described ingreater detail below). Non-mesh sling configurations are also includedwithin the scope of the invention.

The sling mesh may be elastic or inelastic. A mesh may be tested todetermine whether it is elastic using a series IX Automated MaterialsTesting System (an Instron), available from Instron Corporation. A 1 cmwide sample of the mesh may be placed in the Instron with a crossheadspeed set at 5 in/min and a gauge length of 1 inch. An elastic meshexhibits at least a 7% elongation under a ½ pound load, more preferablyabout a 10% elongation under a ½ pound load, and more preferably about14% under the ½ pound load. An inelastic mesh exhibits less than an 7%elongation under a ½ pound load.

In one example embodiment, the mid-portion of the sling mesh ispreferably substantially free of any silicone coatings. In yet anotherembodiment, the mid-portion of the sling may comprise a non-syntheticmaterial, constructed according to the teachings of U.S. ProvisionalPatent Appl. No. 60/405,139, filed Aug. 22, 2002.

In another embodiment the sling material may have one or more substancesassociated therewith through a process such as coating or they may beincorporated into the raw material of the sling. Examples of appropriatesubstances include, without limitation, drugs, hormones, antibiotics,antimicrobial substances, dyes, silicone elastomers, polyurethanes,radiopaque filaments or substances, anti-bacterial substances, chemicalsor agents, including any combinations thereof. The substances may beused to enhance treatment effects, reduce potential sling rejection bythe body, reduce the chances of tissue erosion, enhance visualization,indicate proper sling orientation, and resist infection or othereffects.

While the slings are preferably rectangular for treating SUI in femalesand males, other shapes are also contemplated. Depending on thetreatment addressed (e.g. to provide hammock support for the bladder orbladder neck, or to address a rectocele or enterocele) the slings may beany of a wide variety of shapes. As an example, the sling may be of thegeneral shape of the slings described and shown in Moir et al., TheGauze-Hammock Operation, Journal of Obstetrics and Gynaecology of theBritish Commonwealth, Volume 75, No. 1, Pps. 1-9 (1968). The size of thesling can take into account the imprecision associated with the range ofhuman anatomy sizes. In a preferred embodiment, the sheath length of theassembly of the present invention is approximately within the range of10 cm to 50 cm, sheath width is approximately within the range of 1.0 cmto 2 cm, and sheath material thickness is approximately within the rangeof 0.127 mm to 0.203 mm, respectively. An associated sling has a length,width and thickness approximately within the range of 7 cm to 50 cm; 1.0cm to 2 cm; and 0.508 mm to 0.711 mm, respectively.

Embodiments of surgical implants that include first and second ends, theimplant having a portion that is sized and shaped to extend between atleast one incision substantially adjacent the patient's obturatorforamen and a medial incision that is lateral from and substantiallyparallel to the at least one foramen incision. A tool as describedherein has a handle at one end, the other end having securement surfacessuch as a “dilator” for snap fitting the instrument to another surgicalcomponent used to treat incontinence. The snap fit preferably provides asubstantially permanent attachment between the instrument and the othersurgical component. The instrument and the dilator preferably havecomplementary engagement surfaces for resisting separation of theinstrument from the dilator once they are snap fitted together.

Exemplary implants (e.g., urethral slings) can include a central supportportion and “extension” portions (or “end portions”), the centralsupport portion being useful to support a specific type of pelvic tissuesuch as the urethra, bladder, or vaginal tissue. The central supportportion can be sized and shaped to contact the desired tissue wheninstalled, e.g., as a sling, and support the pelvic tissue.

Exemplary implants are described, for example, in Assignee's copendingU.S. patent application Ser. No. 11/347,063, entitled “Pelvic Implantsand Related Methods, and Ser. No. 11/347,596, entitled “SurgicalImplants and Related Methods and Systems,” both filed on even dateherewith and incorporated herein by reference. These applicationsdescribe implants having reinforced edges extensions along edges of endportions, such as by heat treatment of a polymeric (e.g., polypropylene)mesh, and various types of end portions, central support portions, andother features.

Exemplary pelvic implants can include support portions that can includeor consist of a central support portion, two elongate end portionsextending oppositely from the central support portion, and aload-transfer portion between an end portion and the central supportportion. The implant and the support portions of the implant have alengthwise direction that is considered to be in the direction of theelongate length of the end portions, and a width that is transverse tothe lengthwise direction.

Dimensions of an implant can be as desired and useful for any particularinstallation procedure, treatment, and to support a particular tissue.Dimensions of an exemplary urethral implant for transobturatorimplantation can be sufficient to allow an end portion to extend from alateral incision located adjacent to an obturator foramen of a patient,through the obturator foramen, and then to or near a medial incision(e.g., a vaginal incision in a female or a perineal incision in a male).An opposite end portion has sufficient length to extend from the medialincision, through the opposite obturator foramen, and to another lateralincision adjacent to the opposite obturator foramen. Length and widthtolerances accounts for a range of human anatomy sizes and for aninstallation procedure. Lengths of end portions suitable for othermethods transobturator methods and variations are also contemplated,such as methods wherein a tissue path does not traverse the obturatorforamen, but that extends from the medial incision to the obturatorforamen, and the end portion is attached or anchored to the foramenmembrane but does not pass through to a lateral incision.

A central support portion can be of sufficient length to support andoptionally partially surround a pelvic tissue, e.g., to treatincontinence, such as to support the urethra or urethra-supportingtissue (optionally in combination with some or a portion of the lengthof load-transfer portions). A width of a central support portion isgreater than a width of end portions and is sufficiently wide toincrease contact area and frictional forces between a central supportportion and a tissue in contact with the central support portion.Exemplary lengths of a central support portion can be in the range from0.5 to 2 centimeters, such as from 0.7 to 1.8 centimeters. Exemplarywidths of a central support portion can be in the range from 1.5 to 4centimeters, such as from 2 to 4 centimeters. According to implantembodiments, the combined length of two end portions, a central supportportion, and one or more load-transfer portion or portions, can beapproximately 16 inches (about 41 centimeters), e.g., within the rangefrom 35 cm to 50 cm. Alternate lengths can also be used.

The width of an implant can be as desired and as useful, consistent withthe description herein, such as a central support portion that is widerthan a width of an end portion. A width of an end portion can be a widthuseful for implanting the implant and for providing desired strength andfixation properties during and following implantation and optionaltensioning of the sling. Typical widths of end portions can be in therange from 0.5 to 2 centimeters, e.g., from 0.8 to 1.5 centimeters. Endportions can typically have a uniform or substantially uniform widthalong the length, normally not varying by more than about 25 percent ofthe average width along the length of the installed portion of the endportion.

According to exemplary implants, a central support portion can have awidth that is greater than a width of an end portion, e.g., the width ofthe end portion at a location that is adjacent to a load-transferportion. A central support portion that has a width that is greater thana width of the end portions can improve contact between the implant andtissue to be supported by the implant. An increased width of a centralsupport portion may take the form of one or two lateral extensions or“lobes” that extend laterally in at least one direction (an anteriordirection) for contacting tissue being supported. An anterior extensionsupports tissue that is relatively anterior to a patient's anatomycompared to an otherwise similar central support portion that exhibits asmaller width. Alternately, a central support portion may include twolateral extensions in each of an anterior lateral direction and aposterior lateral direction, to contact tissue both anterior andposterior to a central support portion of a relatively more narrowwidth.

An increased width, e.g., in an anterior direction, can provide forincreased contact and frictional engagement between a central supportportion and pelvic tissue such as a urethra, tissue that supports theurethra, bladder neck, bulbous spongiosum, vaginal tissue, etc., beingsupported. A widened central support portion provides a larger area ofcontact between the implant and a pelvic tissue and can have a reducedtendency to fold or deform upon tensioning of the sling. Increasedcontact area between a central support portion and pelvic tissue canfurther allow for improved ability to re-locate or approximate tissue ifdesired during implantation of the sling and treatment and support ofpelvic tissue by use of the sling. A widened central support portionalso may reduce the amount of pressure (force) exerted onto tissue, perarea of supported tissue, which may reduce risk of tissue necrosis orerosion.

Adjacent to a central support portion, and connecting the centralsupport portion to one or preferably to both end portions, can be one ortwo load-transfer portions. The load-transfer portion exhibits a widththat is greater than a width of an end portion, such as the width of theend portion at the location at which the end portion connects to theload-transfer portion. The load-transfer portion also includes a widththat is less than the width of the central support portion.Functionally, the load-transfer portion allows a load placed across thecentral support portion, between the end portions, to be distributedacross a width of the central support portion that is greater thanwidths of the end portions.

The dimensions of load-transfer portions can be sufficient to allow foroverall functional capabilities of an implant. Exemplary dimensions of aload-transfer portion may include a length extending between an endportion and a central support portion of from about 0.2 to about 2centimeter, such as from about 0.3 to about 0.7 centimeters. The widthof a load transfer portion normally varies between the width of thecentral support portion (where the load-transfer portion connects to thecentral support portion), and the width of the end portion (where theload-transfer portion connects to the end portion). The width canincrease gradually along the length between the end portion and thecentral support portion, either in a straight line, a curved or arcuateline, or otherwise, as desired.

A urethral sling may preferably include two load-transfer portions, oneconnecting each end portion to the central support portion. Aload-transfer portion may extend laterally in an anterior directiontoward a central support portion that is widened in an anteriordirection. Alternately a load-transfer portion may extend bi-laterallyin an anterior direction and in a posterior direction, toward a centralsupport portion that is widened bilaterally in both anterior andposterior directions.

A load-transfer portion may extend between an end portion and a centralsupport portion by a path along an edge that results in a width of aload transfer portion that gradually changes from the width of the endportion to the width of the central support portion. This changing widthmay define a path, along the edge of the load-transfer portion, that isstraight, arcuate, or a combination of straight and arcuate, and thatfunctionally allows a load placed across the central support portion,between the end portions, to be distributed across a width of thecentral support portion that is greater than widths of the end portions.An advantage of a load-transfer portion as described is that the widthof the load-transfer portion, being greater than the width of an endportion, allows for a force applied across the central support portionto be spread out across a greater width of the central support portion(compared to an implant that does not include a load-transfer portion asdescribed herein). Spreading the force to a width that is at leastgreater than the width of the end portions can reduce or preventdeformation of the central support portion upon placing a force acrossthe central support portion. Deformation can be in the form of “curling”of the central support portion when a load is placed in oppositedirections along the end portions.

Exemplary implants include end portions that include side edges(“edges”) and edge extensions. The edge extensions exist due to theporous or “open pore” nature of the material used to prepare the endportion. The edge extensions can be reinforced to cause the end portionto resist movement within tissue, during implantation, afterimplantation, or both. Reinforced edge extensions provide increasedfrictional resistance of an end portion from movement within the tissue,which provides desired short-term fixation properties of end portionswithin tissue during and immediately after installation, i.e., theability of the end portions to stick and hold into flesh when installedwithout moving and potentially without stretching.

Edge extensions can be reinforced by any mode, such as by reinforcingopen pore material adjacent to the edge (e.g., without necessarilytreating the edge itself) in a way that limits movement of edgeextensions and produces a stiffened edge extension. Other reinforcementcan be in the form of a stiffening or reinforcing coating applieddirectly to edge extensions, optionally also adjacent to edgeextensions, to limit the movement of the edge extensions. Reinforcementmay also include combinations of treatments or features of edges or ofareas of porous material adjacent to edges. Thus, a reinforcement mayinclude or contact an edge (i.e., an end of an edge extension), may beadjacent to an edge but not include the edge (end of edge extension)itself, may contact an edge and an area adjacent the edge, or maycontact some portions along an edge of an open pore material and notother portions along the same edge while also including or contactingarea adjacent to the edge. With any of these reinforcements, the forcerequired to pull a reinforced elongate strip through tissue can beincreased.

Without limitation, any useful dimensions between edge extensions,edges, and reinforcement of an extension portion or implant can be usedin association with the invention. Reinforcement can be placed at anyuseful distance from an edge, up to and optionally including thematerial at an edge. As exemplary values, an extension portion can havea length (measured laterally from the end portion as a distanceperpendicular from longitudinal axis of an extension portion) in therange from 0.02 to 0.3 inches, e.g., from 0.05 to 0.1 inches.

Reinforcement located adjacent to an edge and not contacting the edgemay be located a distance sufficiently close to the edge extensions toproduce stiffening of the edge extensions. Typically this location maybe at or near a first junction relative to an edge or at a first solidarea relative to an edge. In terms of distance, a useful distance froman edge may be in the range from 0.02 to 0.3 inches, e.g., from 0.05 to0.1 inches, which can coincide with a first junction or a first solidarea of an end portion material.

A reinforcement adjacent to an edge may be in the form of any type ofmaterial, method, or technique that will improve the strength orstiffness of edge extensions to increase the force required to pass theend portion through tissue. By way of example, a reinforcement mayinclude a material added to or formed or incorporated into an open porematerial at a location adjacent to an edge, and optionally notcontacting the edge (the end of an edge extension). A reinforcingmaterial may be polymeric or non-polymeric, and may be the same as ordifferent from the material of the open pore material itself. Apolymeric material could be a length of interrupted or continuousadhesive, plastic, or thermoplastic materials, or any other polymeric ornon-polymeric material that can be incorporated into the open porematerial at the described location to stiffen and reinforce an edgeextension. A reinforcement adjacent to an edge may alternately oradditionally be in the form of a stiffening weave or knot adjacent to anedge, such as a reinforcing weave or knot at a first junction, that isdifferent from knots or weaves at other positions of an end portion.

An exemplary reinforcement may be a strip of continuous or discontinuoussolid material such as a stiffening strand that is applied to or that isembedded, formed, or woven, or otherwise incorporated, into an open porematerial at a location adjacent to an edge along a length of an endportion. A stiffening strand could be a continuous straight piece ofmaterial that is applied by an adhesive, that is molded into a film, orthat is woven into a mesh, etc. Examples of suitable stiffening strandscould include strands of plastics, bioresorbable materials,thermoplastics, natural materials such as yarns or threads, etc., thatare incorporated into an end portion adjacent to an edge.

Another example of a reinforcement adjacent to a strip edge could be aweave of a mesh that includes different weaving or knots at a junctionor knot adjacent to the edge, e.g., at a first or second junctionrelative to an edge.

Still another example of a reinforcement adjacent to an edge of an endportion of an implant is a heat processed area of film or mesh such as acontinuous or semi-continuous area of heat-treated film or mesh. Heattreatment may melt a polymeric (e.g., thermoplastic) film, strand, ormesh, to cause the film, strand, or mesh, and any adjacent edgeextension, to be strengthened and resist movement, such as at a meltedjunction or knot of a woven mesh. Exemplary heat treatment may be usedto heat treat area of an end portion adjacent to an edge, including oneor more of a first junction, a second junction, a strand or solidportion of an open pore material between the first and second junction,a portion of an edge extension, or any other area of an end portionadjacent to an edge.

Other examples of urethral slings are described in Assignee's copendingU.S. patent application Ser. No. 11/346,750, entitled “TransobturatorSurgical Articles and Methods,” filed on even date herewith, theentirety of which is incorporated herein by reference. That applicationdescribes slings that include a widened central support portion toprovide increased area of contact between the central support portion ofthe sling and the tissue being supported, preferably and optionally incombination with a load transfer portion between end portions and thecentral support portion.

An example of a useful method for preparing an implant having reinforcededge extensions based on heat-treatment is illustrated at FIGS. 9A, 9B,and 9C. FIG. 9A shows a sheet of open pore material 200, which isillustrated as a woven mesh but which may be any open pore material.Mesh sheet 200 is sized substantially larger than the total dimensionsof a mesh implant that will be formed from sheet 200.

FIG. 9A illustrates treated (e.g., heat-treated, coated, etc.) open porematerial 202. Treated material areas 202 can be in the form of lengthsof heat-treated open pore material (e.g., mesh) extending along adesired path of open pore material. As an example, heat-treated openpore material 202 may uniformly contact a longitudinal area thatincludes a series of adjacent pores along a length of mesh 200.Alternately or in addition, heat-treated material 202 may uniformlycontact a longitudinal area that includes a series of adjacent junctionsof mesh strands (e.g., knots) or other junctions or intersections ofmesh 200. Contacting either a series of adjacent pores or junctions of aporous material can result in a uniform pattern of heat-treatedmaterial, e.g., a uniform length-wise area of heat-treated junctions, auniform length-wise of heat-treated pores, or an area that includespores and junctions.

In one specific embodiment a heat-treated material 202 includesheat-treated junctions (e.g., knots or weaves) of a mesh material. Witha location of heat treatment that includes a heat-treated junction of amesh, cutting the mesh can be performed along a line that includes openpores that are immediately adjacent to and substantially parallel to thearea that includes the series of heat-treated junctions. Upon suchcutting step, edge extensions of non-heat-treated severed mesh strandsresult adjacent to elongate areas of heat-treated mesh junctions.

FIG. 9B illustrates an embodiment of a urethral sling cut from mesh 200after formation of heat-treated material 202. Urethral sling 210includes two extension portions 212 extending from central supportportion 214. Sutures 211 extend along the length of implant 210,attached at multiple attachment points 213, which may include adhesive,knots, thermally bonded mesh material, etc. Urethral sling 210 includesa widened central support portion and two load-transfer portions, one oneach side of the central support portion. The load-transfer portions are“bi-arcuate” load transfer portions, meaning that each of the two loadtransfer portions includes two arcuate edges one extending in posteriorand one extending in an anterior direction.

Extension portions 212 include edges 216 extending at the location of acut made in mesh 200, following heat-treatment to form heat-treatedmaterial 202. Each of edges 216 includes edge extensions 218 andreinforcement in the form of heat-treated material 202. FIG. 9Cillustrates a close-up of edges 516, including mesh of extension portion212, edge extensions 218 in the form of severed strand ofun-heat-treated material, and heat-treated material 202 that includes afirst row of fiber junctions (e.g., knots) 220 adjacent to edgeextensions 218.

Still referring to FIG. 9C, the distance of the reinforcement of edgeextensions 218, i.e., heat-treated material 202, from edge 216, can beany distance that stiffens edge extensions 218, and may depend onfactors such as the type of mesh, size of connecting strands of mesh,size of knots, and length of edge extensions. For purposes ofillustration, the two length-wise strips 202 located along each edge 516may be at least 0.05 centimeter (measured laterally, perpendicular tothe length of the edge) from the severed ends of edge extensions 518,e.g., from 0.1 centimeter from the severed ends of edge extensions 518.

A surgical implant such as a sling can be implanted using a needle asdescribed, without the need for bone screws. The precise, final locationof the sling will depend on a variety of factors including theparticular surgical procedure(s) performed, and any preconditions of thepatient such as scar tissue or previous surgeries. For example, it maybe preferred to place the sling in close proximity to, but not incontact with, a mid portion of the urethra to treat incontinence.Alternatively, the sling may be placed near the bladder neck or near thebulbous spongiosum (BC).

Tools of the invention can be used for transobturator methods in maleand female anatomies, e.g., to implant a urethral sling (“sling”) totreat urinary incontinence. “Transobturator” methods generally involvetwo lateral incisions at the left and right inner thigh regions, eachnear a patient's obturator foramen, and a third, medial externalincision at the perineum. The sling is installed between the medialincision and the two lateral incisions with a central support portion ofthe sling being placed below the urethra, to support the urethra, notnecessarily in contact with the urethra itself but optionally andpreferably in contact with tissue below the urethra. The sling can bethen tensioned to approximate pelvic tissue to improve continence.Transobturator methods are described in Assignee's copending U.S. patentapplication Ser. No. 11/347,047, entitled “Transobturator Methods forInstalling Sling to Treat Incontinence, and Related Device,” filed oneven date herewith; the entirety of which is incorporated herein byreference.

According to U.S. Ser. No. 11/347,047, titled Transobturator Methods forInstalling Sling to Treat Incontinence, and Related Device, filed oneven date herewith, a patient may suffer from pelvic tissue prolapse,weakness, or dislocation, due to one or more factors of age, weak andsagging perineal floor muscles, as a result of a surgical procedure tothe prostate such as a partial or radical prostatectomy, or for anyother reason. Pelvic tissue prolapse may be in the form ofmis-positioning of one or more component pelvic tissue that makes up theurinary sphincter complex. A urethral sling can be installed toapproximate and support pelvic tissue, e.g., of the urethra, perinealbody, urethral sphincter complex, etc., in any way that improvespositioning of pelvic tissue to improve coaptation of the urethra,resulting in improved continence. According to one embodiment describedtherein, a central support portion of a sling may be placed below thebulbospongiosus muscle and tensioned to re-position pelvic tissue andimprove continence. In particular embodiments for treating maleincontinence, a urethral sling can be installed using a tool asdescribed herein, and a transobturator tissue path, by placing a centralsupport portion of a sling in direct contact with the corpus spongiosum.

In other embodiments of a transobturator method, a single needle may beuseful to place left and right end portions both left and right sides ofa patient. A single left-handed needle (alternately a singleright-handed needle) can be used to place a right side of the sling on apatient's right side, using a transobturator tissue path between aperineal incision and a patient's right-side lateral incision. In thesame procedure, the same left-handed needle may also be used to placethe opposite end portion on the patient's left side. While theleft-handed needle is not optimal for placement at the patient's leftside, it can be effective. Systems or kits of the invention can includea single left- or right-handed needle with an implant, for surgicalimplant according to this method.

The invention also includes surgical kits, assemblies, and systems thatinclude at least one tool, optionally two tools, as described herein. Ina preferred embodiment, a kit comprises at least on surgical instrumentsuch as one of those shown in any of FIGS. 1-6, and a urethral slingsuch as a polypropylene sling mesh assembly with attached dilators. Sucha kit may be provided for the placement of a sling for the treatment ofmale and female stress urinary incontinence (SUI) resulting fromurethral hypermobility and/or intrinsic sphincter deficiency. Exemplarykits may include a tool arranged to provide an ergonomic advantage asdescribed and a urethral sling. In a kit for the male anatomy (or alarger female anatomy) a tool may be sized or shaped with largerdimensions such as a larger width or length of a three-dimensionalportion; the sling may be designed for use in the male anatomy withincreased strength and short and long-term fixation properties. Thesling may be designed, for example, for placement below the CS, mayinclude a widened central support portion, load transfer portions,reinforced edge extensions, multiple sutures, sutures attached atmultiple attachment points, etc.

The various embodiments of three-dimensional needles described abovepreferably include a substantially straight spacer portion emerging froman end of the handle portion preferably along the handle axis. Thishelps afford convenient passage of the needle using an ergonomic wristroll adopted by some surgeons. The three dimensional needles alsoinclude a structure that can be described as a variable spiral portionextending from the distal end of the straight spacer portion. As shown,the spiral portion is preferably variable as the angle of the spiralportion changes between the end of the extension portion and the distalend of the needle. The shape of the spiral portions help avoid overinsertion of the needle into the body which helps avoid damage to thesensitive structures in this region of the body.

All patents, patent applications, and publications cited herein arehereby incorporated by reference in their entirety as if individuallyincorporated.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

EXAMPLES OF SURGICAL PROCEDURES Example 1

Several methods are contemplated herein. Although the methods of use asdisclosed herein generally relate to female incontinence conditions andtreatments/procedures, male incontinence conditions andtreatments/procedures are also included within the scope of the presentinvention. Further, the term “urethra,” with respect to slingpositioning, is used for brevity and reader convenience. It should benoted that the present invention is particularly suitable for placing asling in a therapeutically effective position. The method may be used tosupport a variety of structures at different anatomical locations.Variations of these methods may occur due to individual surgeon'stechniques or a patient's particular anatomy.

The present invention uses an obturator passage of the needle,preferably in a direction from the anterior to the posterior side of thepubic bone. An obturator approach affords a sling procedure whereprevious scarring in the region of the retropubic space or otheranatomical features would prevent or restrict a traditional pubomedialsling procedure. An obturator approach is also likely to avoid bladderperforations, a possible but rare complication with some prior artpubomedial procedures. It may also be more convenient to conduct aconcomitant repair (e.g. cystocele repair) with a sling inserted with aside approach as the sling is placed in a more horizontal position thanthe U-shaped sling procedures of the prior art.

Initially, the patient is placed under local, spinal, or generalanesthesia. A small transverse or medial incision is made in theanterior medial wall of a patient followed by a transurethraldissection. The amount of dissection may vary according to surgeonpreference. Preferably, dissection is sufficient to allow the surgeon'sfinger to meet the end of the three-dimensional region of a needle asdescribed herein, after the needle passes through the obturator foramen.

Two small incisions are also made near the obturator foramen to affordneedle entry. Notably, the precise location of the stab incisions mayvary according to surgeon preference. For example, some surgeons mayplace the incision adjacent the obturator opening of the pubic bone.Other surgeons may slightly offset the incision in order to use the biasprovided by the patient's tissue to urge the tip of the needle in adirection toward the posterior surface of the pubic bone.

The surgeon's finger is initially placed in the medial incisionsufficient to meet the end of region of the needle after it passesthrough the obturator foramen. A path for the needle through theobturator foramen that is substantially free of vascular and nervepassages is selected. To select the path, the surgeon preferablyinitially identifies the anatomical structures of the pelvis such as theischial tuberosity and obturator foramen by palpation of the tissue.

In one example embodiment, the surgeon seeks to use the posteriorportion of the patient's pubic bone as an anatomical guide tocontrollably move the tip of region of the needle toward the medialincision and to help avoid damaging structures. The surgeon exploits thetactile feel provided by the posterior portion of the pubic bone tocontrollably pass the tip of the needle. This approach is preferred asit helps keep the needle away from the bladder and other vulnerabletissues.

The sling is placed in a therapeutically effective position. Otherpositions are contemplated herein. The precise anatomical position willdepend upon a variety of factors including the type and degree ofanatomical damage or insufficiency, location of significant scar tissue,whether the sling procedure is combined with other procedures and othersurgeon decisions. The sling can be placed in one of various usefulpositions to treat a pelvic condition, such as to support the bulbousspongiosum (BC), the urethra (directly), or another tissue to supportthe floor of the pelvis.

Example 2

Exemplary Male Transobturator Sling System and Method

An exemplary sling system consists of two single-use surgicalinstruments called “needle passers” (“tool” or “needle”) and a meshimplant with attached connectors, provided sterile. One end of eachneedle passer is keyed to allow for secure placement of the dilatingconnectors. Each needle passer has a plastic handle attached. The meshis constructed of polypropylene monofilament that is precut to 1.2centimeters arm width, 3.55 centimeters center width, and 35.5centimeters length. Two absorbable tensioning sutures are threaded intothe length of the sling system mesh to allow for tensioning adjustmentof the sling system mesh after placement in the patient. Two plasticsheaths are placed over each arm of the sling system mesh to aid in easeof placement. The dilating connectors are attached to the ends of theneedle passers during the procedure. The mesh is intended to remain inthe body as a permanent implant and the mesh component is not absorbedor degraded by the action of tissue in-growth or tissue enzymes.

The system is intended for the placement of a pubourethral sling systemfor the treatment of male stress urinary incontinence (SUI) or intrinsicsphincter deficiency (ISD).

The procedure can be carried out under local, regional or generalanesthesia. A small vertical incision is made in the area of theperineum followed by periurethral dissection. Two small stab incisionsare also made above the obturator foramen for needle entry.

Preparation

-   1. Patient should be placed in a dorsal lithotomy position.-   2. Genital area should be shaved.-   3. After shaving, the area should be scrubbed with Povidone-iodine    soap for ten minutes or the approved hospital pre-operative scrub    procedure.-   4. Ensure that the bladder is empty. A Foley catheter is not    required but may aid in identifying the urethra during the    procedure.    Dissection-   1. The scrotum is elevated and a perineal incision is made,    beginning midline at the level of the inferior edge of the symphasis    and running approximately three centimeters toward the rectum.-   2. The incision is carried deeper through Colles' fascia. The    urethra is then mobilized by separating the bulbocavernosus muscle    from the central tendon of the perineum.-   3. The bulbocavernosus muscle is separated at the midline raphe and    carefully dissected away from the corpus spongiosum.-   4. A finger is placed between the bulbocavernosus muscle and the    corpus spongiosum and with blunt dissection, the intersection of the    corpus spongiosum and the perineal membrane is found.-   5. The needle is inserted into the obturator foramen at a point    bordering the inferior pubic ramus defining the foramen which lies    approximately one-third of the distance below the forminal apex.    Palpate the inferior pubic ramus and feel for the bony landmarks to    locate the proper position. A needle through the skin can be used to    probe the bone to help confirm that the correct location for the    needle passer entry point is found, but it is not required. The    position of entry is just below the medial aspect of the palpable    part of the adductor longus tendon. The ideal position is at a point    at the inner and medial aspect of the obturator foramen as high as    possible to the foraminal apex.-   6. Make small stab incisions at the correct location over both    obturators (obturator foramina). Confirm that both marks lie in a    straight line at the level shown in FIG. 6.-   7. The patient is now ready for needle passage.    Passing the Insertion Needle Through the Obturator Foramen-   1. Identify needle designated for the patient's left side.-   2. Point the needle tip perpendicular to the skin and insert the    needle into the patient's left stab incision previously made over    the obturator foramen. The goal is to start with the needle tip    hugging the medial aspect of the inferior pubic ramus within the    obturator foramen at the level of the point one third below the    cephalad peak of the obturator foramen.-   3. Insert the needle to the level of the obturator fascia while    hugging the bone with the needle tip.-   4. Place an index finger in the perineal incision between the    intersection of the corpus spongiosum and the perineal membrane on    the side of the corpus spongiosum closest to the needle entry point.-   5. When passing the needle on the patient's left side, keep the    surgeon's right hand on the needle handle and left index finger in    the perineal incision. The surgeon's left thumb should be on outside    curve of needle to control the needle movement.    See FIGS. 10 and 11.-   6. Using the left thumb on the outside curve of the needle for to    control needle movement, push the needle through the muscles and    obturator fascia by turning the needle handle clockwise using the    right hand. The needle tip penetrates until resistance of the tissue    stops—about 0.5 centimeters.-   7. Immediately locate the ischial pubic ramus with the needle tip    and rotate the needle handle to allow the needle to follow the    posterior ischial pubic ramus surface.-   8. The index finger tip must palpate the needle tip while the needle    is under the perineal membrane. The goal is to have the needle tip    pass through the perineal membrane medial to the ischiocavernosus    muscle, lateral to the corpus spongiosum and just below the level    where the urethra passes through the perineal membrane. If not, move    the needle to meet the finger tip. If the needle tip cannot be    located, then the needle must be withdrawn just behind the ischial    pubic ramus and carefully advanced again.-   9. When the needle tip is in the correct position, guide the needle    tip using the index finger through the perineal membrane until the    needle extends through the incision.-   10. Repeat the needle passage procedure (steps 2-9) on the patient's    right side, with the needle designed for the right side.    Placing the Sling System Mesh-   1. Attach connector from the implant to needle end. One connector    should be attached to each of the needles on the end protruding from    the perineal incision. Orient the knots of the tensioning sutures to    be facing outward, away from the urethra. Be sure that the sling    system mesh lies flat and that the mesh is not twisted prior to    attaching each connector.-   2. Once both ends are connected, retract one needle along the same    pathway, guiding with the fingertip.-   3. Cut the insertion sheath and mesh at the external end of the    plastic sheath and discard the needle, attached connector, sheath    end, and mesh end. This step allows the sheath to slide freely    relative to the mesh. Leave enough sheath material above the level    of the skin so that the sheath can later be removed.-   4. Repeat for the other needle on patient's contra lateral side to    loosely position the sling system with the tensioning sutures facing    outward, away from the urethra. Loosely position the sling system    with the center of the central portion of the mesh sling    approximately 1 centimeter distal to the line created between the    needle passages on both sides of the corpus spongiosum.-   5. In an optional step, before tensioning the sling, use two tack    sutures to secure the placement of the sling to the midline of the    corpus spongiosum. The sutures should be placed through the distal    “flap” (anterior extension of the central support portion of the    sling) just off of the center of the sling (at least two pores in    from the edge of the sling mesh) and pass shallowly through the    midline of the corpus spongiosum. When the sling is tensioned it    will reposition the posterior urethral bulb approximately 14    centimeters proximal while elevating the perineal membrane.-   6. The traction is parallel to the posterior urethra, which    repositions the urethral lumen, rather than obstructing it.    Adjusting the Sling System Tension-   1. If tissue retraction has been used, it must be removed before    adjusting the tension of the sling system. If a Foley catheter has    been used, it must also be removed before adjusting the tension.-   2. The mesh is properly tensioned by simultaneously pulling on the    ends of the sling system mesh and noticing approximately 14    centimeters proximal movement of the urethra.-   3. If the patient is under spinal or regional anesthesia, the    position of the sling can be verified by a cough test after filling    the bladder, at the discretion of the surgeon.

To Loosen the Sling System Mesh:

Place an instrument between the sling system mesh and the urethra.Ensure that both the mesh and the tensioning sutures are located beneaththe clamp. Use the clamp to pull down and loosen the sling system meshas desired.

To Tighten the Sling System Mesh:

Clamp a device such as a hemostat, across the sling system mesh, at thelateral incisions. Be sure that both the tensioning sutures and thecomplete width of the sling system are captured within the clamp. Thesling system mesh may be rolled around the clamp to improve the grip.Pull up to tighten the sling system mesh as desired. If needed, this canbe repeated on the contra lateral side.

Remove the plastic sheath from the sling system mesh and discard.Confirm the correct tension of the sling system after the sheath hasbeen removed.

Trim the sling system mesh at the level of the subcutaneous tissue.

Complete a multi-layer closure of the perineal incision and the skinincisions.

Immediate Post-Operative Care

A catheter can be used at the discretion of the surgeon.

Antibiotic prophylaxis should be given.

The ability of the patient to empty the bladder should be confirmed.

Example of Method of Preparation of Urethral Sling with Widened CentralSupport Portion and Reinforced Edge Extensions

Exemplary urethral sling implants according to the invention wereprepared according to the following, by the steps, in order, of (1)providing a sheet of mesh material, (2) heat treating the mesh toproduce a heat treated area, and (3) cutting the heat treated mesh toform a urethral sling that includes reinforced edge extensions on endportions.

Step 1—Heat Treating or “Sealing” Mesh

A sheet of polypropylene knitted mesh was provided for treatment in aheat-treatment or heat-sealing machine. The mesh was of the type used inthe MONARC™ and SPARC® female urethral slings used for treating femaleurinary incontinence, from American Medical Systems, Inc., of MinnetonkaMinn. The mesh is that type that includes a “smooth” side and a “rough”side, as is known. The rough side may have a very slightly more roughfeel compared to the smooth side; with reference to the direction of theloop that forms the weave, the loop points slightly more toward the“rough” side surface and slightly away from the “smooth” side surface.The “rough side” may be referred to as the “Technical Face” or “LoopSide” and the “smooth side” is called the “Technical Back” or “LapSide”. The invention can preferably apply heat (“sealing”) at theTechnical Back side of this type of mesh.

The pores are diamonds that have a size including an approximately0.060″ diameter measured (corner to corner) at the longer dimension anda 0.050″ diameter measured in the shorter “width” direction (corner tocorner). The sheet has rows of alternating diamonds that face up (thesmallest angle point of the diamond faces up) adjacent to diamonds thatface down (the smallest angle point of the diamond faces down).

The machine was turned on and set machine to the following cycleparameters:

Temp of heated sealing element: 395° F. (±5° F.) Pressure applied tomesh by sealing element 35 psi (±5 psi) Time of pressure application 0.9sec (±.1 sec)

The mesh was loaded rough-side-down onto a plate insert that includes aline of several pins that are inserted into the pores of the mesh. Theplate insert fits into a groove for positioning the plate and mesh belowa heat treating element and a cutting die, for heat treating and cuttingat locations of the mesh to produce heat treated reinforcement adjacentto edges, i.e., reinforced edge extensions. A portion of a plate isshown at FIG. 13, which shows plate 300 and pins 302 (not to scale).Pins 302 are not at the center of the width of the plate but are locatedcloser to one side (referred to as the “short side,” and indicated withthe arrow) than the other side. This is because of the asymmetry of the“diamond”-shaped pores used to prepare the urethral sling of the presentexample. The offset of the pins allows a cut of the mesh to align withpore openings as desired, and also allows heat sealing to align asdesired, e.g., at a first junction of the mesh.

The mesh is aligned such that the pins of the plate are placed in thesame row of pores of a mesh, with the pores being aligned along thelength of the end portion as diamond-shapes as opposed to square-shapes(see FIG. 14). More specifically, because the diamonds of areasymmetrical, the diamonds are aligned with an orientation that pointsthe smaller angle of the diamond in a direction away from the “shortside” of the plate (indicated by arrows), i.e., the “diamond facing up”pores are held by pins 302. See FIG. 14, which schematically illustratesthat pins 302 located to hold a single “row” of upward-facing diamonds304, of with all diamonds held by pins 302 facing in the same direction.

A “mesh hold-down” piece is used to hold the mesh against the plate. Thehold-down is made of Teflon and fits over the mesh and pins of the plateand does not otherwise interfere with the heating element contacting themesh.

Load the mesh and plate into the heat seal machine, making sure the meshis laying flat. Initiate heat treatment cycle with the parametersidentified above.

Remove Mesh Hold-Down.

Step 2—Die Cutting the Sling

A pneumatic press, cutting die, plate insert, and attached mesh (above)are provided. The die includes a blade that is shaped like a one-pieceurethral sling, with the following dimensions, as shown in FIG. 12.

Measured Dimension Value A 0.44″ B 0.44″ C  1.4″ D   14″ E 0.58″ F  1.5″

The pneumatic press is set to 55 psi (±5 psi).

The plate with the mesh on it is placed into the cutting die. This linesup the cut to be adjacent to the heat-treaded portion of the mesh.

The die and mesh are placed in to the pneumatic press and the stampingcover with the plastic side down is placed on to the die.

The press is activated to cut out the sling.

If any strands of the sling did not cut, a pair of scissors can be usedto separate the sling from the mesh panel along the cutting line of thedie.

If necessary, edges of the sling may be cleaned with a bristled brush toremove any loose sling material.

1. A surgical instrument for implanting an implantable material to apelvic region, the instrument comprising: a handle having a longitudinalaxis and an elongate width dimension normal to the longitudinal axis,the elongate width dimension defining a midplane, a needle portionextending from the handle along the longitudinal axis, the needleportion comprising a spacer portion connected to the handle, athree-dimensional region connected to the spacer portion distal from thehandle, and having structure in three dimensions, and a needle distalend at the distal end of the three-dimensional region, wherein theneedle portion is sized and shaped to extend between an incisionsubstantially adjacent to a patient's obturator foramen, through theobturator foramen, and to a medial incision; and wherein the needledistal end is located at an angle between 20 to 70 degrees from themidplane when viewed along the longitudinal axis, and wherein an anglebetween an axis of the needle end portion and the midplane, the anglebeing an acute angle defined by the needle tip, an intersection of theaxis and midplane, and the longitudinal axis when viewed along thelongitudinal axis, is in the range from 30 degrees to 60 degrees.
 2. Theinstrument of claim 1, wherein the three-dimensional region defines acurved portion comprising a needle end portion, and an axis of theneedle end portion lies in a plane orthogonal to the longitudinal axisof the tool.
 3. The instrument of to claim 1, wherein thethree-dimensional region comprises a portion shaped like a spiral,helix, or partial helix.
 4. The instrument of claim 1, comprising aneedle end portion at a terminal inch of the three-dimensional regionthat comprises a curve.
 5. The instrument of claim 4, wherein an anglebetween the axis of the needle end portion, and a circle having anorigin at the longitudinal axis and a radius defined by the needledistal end, when viewed along the longitudinal axis, is less than 15degrees.
 6. The instrument of claim 1, designed for use in a maletransobturator sling installation procedure, wherein the needle portionis sized and shaped to extend between an incision substantially adjacentto a patient's obturator foramen, through the obturator foramen, and toa perineal incision, the three-dimensional region has a length in therange from 2.2 to 4 inches and a diameter in the range from 2.3 to 5inches, and the three-dimensional region defines a helix that includesan axis of a needle end portion within a plane orthogonal to thelongitudinal axis of the tool.
 7. The instrument of claim 1 designed foruse in a male transobturator sling installation procedure, by dissectinga transobturator tissue using an outside-in dissection technique.
 8. Theinstrument of claim 1 in combination with a surgical implant fortreating incontinence, wherein the implant comprises a central supportportion and two elongate end portions, and wherein the needle endportion is adapted to be associated with an end portion of the implant.9. The combination of claim 8, wherein the implant is a male urethralsling comprising one or more of a widened central support portion,reinforced edge extensions, or both.
 10. A method of treating maleincontinence comprising the steps of: creating a pair of lateralincisions substantially adjacent a patient's obturator foramen, creatinga medial incision medial to the pair of lateral incisions, providing asurgical instrument according to claim 1, having a securement surface atthe needle distal end, providing an implantable assembly adapted fortreating the incontinence, the assembly having a surface complementaryto the securement surface, passing the three-dimensional region havingthe securement surface between a lateral incision and the medialincision and through an obturator foramen, then associating theinstrument at the securement surface with the implantable assembly toprovide a removable attachment between the instrument and the assembly,then passing the implantable material through tissue from the medialincision toward a lateral incision.
 11. The method of claim 10, whereinthe three-dimensional region comprises a portion shaped like a spiral,helix, or partial helix.
 12. The method of claim 10, wherein an anglebetween the axis of the needle end portion and circle having an originat the longitudinal axis and a radius defined by the needle distal end,when viewed along the longitudinal axis, is less than 15 degrees. 13.The method of claim 10, wherein the three-dimensional region has alength in the range from 2.3 to 5 inches and a diameter in the rangefrom 2.3 to 5 inches, and an axis of the needle end portion lies withina plane that is orthogonal to the longitudinal axis of the tool.
 14. Theinstrument of claim 13, wherein a radial distance from a longitudinalaxis of the spacer, to the needle distal end, is in the range from 0.7to 1.4 inches.
 15. The instrument of claim 1 wherein: thethree-dimensional region defines a curved portion comprising a needleend portion, and an axis of the needle end portion lies in a planeorthogonal to the longitudinal axis of the tool, the three-dimensionalregion comprises a portion shaped like a spiral, helix, or partialhelix, a needle end portion at a terminal inch of the three-dimensionalregion comprises a curve, and an angle between the axis of the needleend portion and a circle having an origin at the longitudinal axis and aradius defined by the needle distal end, when viewed along thelongitudinal axis, is less than 15 degrees.
 16. The method of claim 10,wherein the needle distal end is located at an angle between 20 to 70degrees from the midplane when viewed along the longitudinal axis, andan angle between an axis of the needle end portion and the midplane,when viewed along the longitudinal axis, is in the range from 30 degreesto 60 degrees.
 17. The method of claim 16, wherein a terminal inch ofthe needle end portion comprises a curve.
 18. The method of claim 12,wherein the needle distal end is located at an angle between 20 to 70degrees from the midplane when viewed along the longitudinal axis, andan angle between an axis of the needle end portion and the midplane,when viewed along the longitudinal axis, is in the range from 30 degreesto 60 degrees.
 19. The method of claim 18, wherein a terminal inch ofthe needle end portion comprises a curve.
 20. A surgical instrument forimplanting an implantable material to treat incontinence, the instrumentcomprising: a handle comprising a longitudinal axis, needle extendingfrom the handle, the needle comprising a spacer portion connected to thehandle, and a three-dimensional region connected to the spacer portiondistal from the handle, and having structure in three dimensionsincluding a needle distal end at the distal end of the three-dimensionalregion, wherein the needle portion is sized and shaped to extend betweenan incision substantially adjacent to a patient's obturator foramen,through the obturator foramen, and to a perineal incision; thethree-dimensional region has a length in the range from 2.3 to 5 inchesand a diameter in the range from 2.3 to 5 inches, and an axis of theneedle end portion lies within a plane that is orthogonal to thelongitudinal axis of the tools, wherein an angle between an axis of theneedle end portion and a tangent of a circle having an origin at thelongitudinal axis and a radius extending to the needle distal end, whenviewed along the longitudinal axis, is less than 15 degrees.
 21. Theinstrument of claim 20, wherein a radial distance from a longitudinalaxis of the spacer, to the needle distal end, is in the range from 0.7to 1.4 inches.
 22. A method of treating urinary incontinence in a male,the method comprising creating a pair of lateral incisions substantiallyadjacent a patient's obturator foramen, creating a medial incision atthe perineum, medial to the pair of lateral incisions, providing asurgical instrument comprising, a handle having a longitudinal axis andan elongate width dimension normal to the longitudinal axis, theelongate width dimension defining a midplane, a needle portion extendingfrom the handle along the longitudinal axis, the needle portioncomprising a spacer portion connected to the handle, a three-dimensionalregion connected to the spacer portion distal from the handle, andhaving structure in three dimensions, and a needle distal end at thedistal end of the three-dimensional region, the needle distal endcomprising a functional section that engages a surgical implant,providing an implantable assembly adapted for treating the incontinence,the assembly having a surface complementary to the functional section,engaging the functional section of the needle distal end with thesurface of the implantable assembly, passing the three-dimensionalregion having the functional section between a lateral incision and themedial incision and through an obturator foramen by grasping the handlewith the midplane approximately parallel to the palm and rotating thehandle using the hand such that during the rotation the handle rotatesat least ninety degrees, and during ninety degrees of the rotation thehand traverses ninety degrees between a forty-five degree open palm anda forty-five degree closed palm, wherein the needle distal end islocated at an angle between 20 to 70 degrees from the midplane, whenviewed along the longitudinal axis, and an angle between an axis of theneedle end portion, and the midplane, the angle being an acute angledefined by the needle tip, an intersection of the axis and midplane, andthe longitudinal axis, when viewed along the longitudinal axis, is inthe range from 30 degrees to 60 degrees.
 23. The method of claim 22,wherein the functional section of the tool is capable of dissectingtissue.
 24. The method of claim 22, wherein the functional section ofthe tool comprises a three-dimensional region of a needle.
 25. Themethod of claim 22, wherein the surgical instrument comprises a handlehaving a longitudinal axis and an elongate width dimension normal to thelongitudinal axis, the elongate width dimension defining a midplane, aneedle portion extending from the handle along the longitudinal axis,the needle portion comprising a spacer portion connected to the handle,a three-dimensional region connected to the spacer portion distal fromthe handle, and having structure in three dimensions, and a needledistal end at the distal end of the three-dimensional region, whereinthe needle portion is sized and shaped to extend between an incisionsubstantially adjacent to a patient's obturator foramen, through theobturator foramen, and to a medial incision; and wherein the needledistal end is located at an angle between 20 to 70 degrees from themidplane when viewed along the longitudinal axis, and wherein an anglebetween an axis of the needle end portion and the midplane, the anglebeing an acute angle defined by the needle tip, an intersection of theaxis and midplane, and the longitudinal axis when viewed along thelongitudinal axis, is in the range from 30 degrees to 60 degrees, andfurther comprising a needle end portion at a terminal inch of thethree-dimensional region that comprises a curve.
 26. The method of claim22, wherein the surgical instrument comprises a handle comprising alongitudinal axis, needle extending from the handle, the needlecomprising a spacer portion connected to the handle, and athree-dimensional region connected to the spacer portion distal from thehandle, and having structure in three dimensions including a needledistal end at the distal end of the three-dimensional region, whereinthe needle portion is sized and shaped to extend between an incisionsubstantially adjacent to a patient's obturator foramen, through theobturator foramen, and to a perineal incision; the three-dimensionalregion has a length in the range from 2.3 to 5 inches and a diameter inthe range from 2.3 to 5 inches, and an axis of the needle end portionlies within a plane that is orthogonal to the longitudinal axis of thetool, wherein an angle between an axis of the needle end portion and atangent of a circle having an origin at the longitudinal axis and aradius extending to the needle distal end, when viewed along thelongitudinal axis, is less than 15 degrees.